Coronary Artery Disease, Atherosclerosis
Conditions
Keywords
calcified plaque, angioplasty, cutting balloon
Brief summary
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
Detailed description
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio. The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
Interventions
PROCEDURErotational atherectomy
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
DEVICEcutting balloon
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
DEVICEplain old balloon
current standard treatment of stent placement
Sponsors
Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults Patients ≥18 years of age * Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography * Patients eligible for percutaneous coronary intervention
Exclusion criteria
* Patients in cardiogenic shock * Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period * Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction * Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, \< 2 years postmenopausal, or does not consistently use effective methods of contraception * Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months * Currently participating in another investigational drug or device study * Patients referred to coronary artery bypass grafting after heart team discussion Angiographic Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Stent Area After Percutaneous Coronary Intervention | Post-procedure, Day 0 | Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention | 30 days | Non-Cardiac Death |
| In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation | Post-procedure, Day 0 | In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound |
| Minimum Percent Stent Expansion After Percutaneous Coronary Intervention | Post-procedure, Day 0 | Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound |
| Mean Percent Stent Expansion After Percutaneous Coronary Intervention | Post-procedure, Day 0 | Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound |
| Number of Participants With Dissection After Percutaneous Coronary Intervention | Post-procedure, Day 0 | Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound. |
| Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention | Post-Procedure, Day 0 | Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall. |
| Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA) | Post-CBA/NCBA before stent, Day 0 | Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall |
| Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon | Post-Procedure, Day 0 | Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area. |
| Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography | Post-procedure, Day 0 | Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement). |
| Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography | Post-procedure, Day 0 | Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement). |
| Percent Residual Diameter Stenosis In-segment After Stent Implantation | Post-procedure, Day 0 | Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography |
| Percent Residual Diameter Stenosis In-stent After Stent Implantation | Post-procedure, Day 0 | Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography |
| Minimum Lumen Diameter In-segment After Stent Implantation | Post-procedure, Day 0 | Minimum lumen diameter in-segment after stent implantation assessed by Angiography |
| Minimum Lumen Diameter In-stent After Stent Implantation | Post-procedure, Day 0 | Minimum lumen diameter in-stent after stent implantation assessed by Angiography |
| Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention | 30 days | Cardiac Death |
| Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation | Post-procedure, Day 0 | Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel |
| Number of Participants With Side Branch Closure After Stent Implantation | Post-procedure, Day 0 | Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch |
| Number of Participants With a Balloon Rupture | Post-Procedure, Day 0 | Device problem; Rupture of the cutting balloon or plain old balloon |
| Number of Participants With Blade Detachment | Post-Procedure, Day 0 | Device problem; detachment of a blade from the cutting balloon |
| Number of Participants With Difficulty in Withdrawing/Advancing the Device | Post-Procedure, Day 0 | Device problem; difficulty in moving the balloon within the vessel during the procedure |
| Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention | 30 days | — |
| Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention | 30 days | The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes. |
| Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention | 30 days | Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition. |
| Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention | 30 days | Revascularization |
| Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention | 30 days | Revascularization |
| Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention | 30 days | Stent Thrombosis |
| Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention | 30 days | Bleeding Academic Research Consortium (BARC) Type 3 1. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding 2. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 5 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation) |
| Number of Participants With Vascular Complications After Percutaneous Coronary Intervention | 30 days | Vascular complication |
| Angina Status According to Canadian Cardiovascular Society (CSS) Classification | 270 days | The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity. Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work. Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace. Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace. Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest. Higher grades indicate more limitations to activity due to angina. |
| Number of Participants With Dissection Type B or Greater | Post-CBA/NCBA before stent and after stent, Day 0 | Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotational Atherectomy + Cutting Balloon angioplasty with rotational atherectomy followed by cutting balloon
rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
cutting balloon: a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs | 29 |
| Rotational Atherectomy + Plain Old Balloon angioplasty with rotational atherectomy followed by plain old balloon
rotational atherectomy: angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
plain old balloon: current standard treatment of stent placement | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Rotational Atherectomy + Cutting Balloon | Rotational Atherectomy + Plain Old Balloon | Total |
|---|---|---|---|
| Age, Continuous | 69.2 years STANDARD_DEVIATION 10 | 72.8 years STANDARD_DEVIATION 8.7 | 71.1 years STANDARD_DEVIATION 9.4 |
| Cerebrovascular disease | 3 Participants | 5 Participants | 8 Participants |
| Chronic renal insufficiency | 5 Participants | 2 Participants | 7 Participants |
| Current smoker | 3 Participants | 6 Participants | 9 Participants |
| Diabetes mellitus | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 27 Participants | 52 Participants |
| Family history of coronary artery disease (CAD) | 15 Participants | 18 Participants | 33 Participants |
| Hyperlipidaemia | 28 Participants | 29 Participants | 57 Participants |
| Hypertension | 28 Participants | 29 Participants | 57 Participants |
| Insulin | 6 Participants | 5 Participants | 11 Participants |
| Left ventricular ejection fraction (LVEF) | 55.6 percent STANDARD_DEVIATION 9.8 | 57.3 percent STANDARD_DEVIATION 7.6 | 56.5 percent STANDARD_DEVIATION 8.7 |
| Peripheral arterial disease | 4 Participants | 3 Participants | 7 Participants |
| Prior coronary artery bypass grafting (CABG) | 2 Participants | 2 Participants | 4 Participants |
| Prior myocardial infarction (MI) | 4 Participants | 7 Participants | 11 Participants |
| Prior percutaneous coronary intervention (PCI) | 20 Participants | 20 Participants | 40 Participants |
| Prior stroke | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 12 Participants | 20 Participants | 32 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 21 Participants | 26 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 24 / 29 | 28 / 31 |
| serious Total, serious adverse events | 4 / 29 | 4 / 31 |
Outcome results
Primary
Minimum Stent Area After Percutaneous Coronary Intervention
Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Minimum Stent Area After Percutaneous Coronary Intervention | 6.7 mm^2 | Standard Deviation 1.7 |
| Rotational Atherectomy + Plain Old Balloon | Minimum Stent Area After Percutaneous Coronary Intervention | 6.9 mm^2 | Standard Deviation 1.8 |
Secondary
Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography
Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography | 1.0 mm | Standard Deviation 0.4 |
| Rotational Atherectomy + Plain Old Balloon | Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography | 1.1 mm | Standard Deviation 0.3 |
Secondary
Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography
Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography | 1.5 mm | Standard Deviation 0.3 |
| Rotational Atherectomy + Plain Old Balloon | Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography | 1.6 mm | Standard Deviation 0.4 |
Secondary
Angina Status According to Canadian Cardiovascular Society (CSS) Classification
The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity. Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work. Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace. Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace. Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest. Higher grades indicate more limitations to activity due to angina.
Time frame: 270 days
Secondary
In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation
In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation | 5.9 mm^2 | Standard Deviation 1.4 |
| Rotational Atherectomy + Plain Old Balloon | In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation | 6.4 mm^2 | Standard Deviation 1.9 |
Secondary
Mean Percent Stent Expansion After Percutaneous Coronary Intervention
Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Mean Percent Stent Expansion After Percutaneous Coronary Intervention | 112.5 mean percent expansion | Standard Deviation 19.4 |
| Rotational Atherectomy + Plain Old Balloon | Mean Percent Stent Expansion After Percutaneous Coronary Intervention | 104.2 mean percent expansion | Standard Deviation 13.5 |
Secondary
Minimum Lumen Diameter In-segment After Stent Implantation
Minimum lumen diameter in-segment after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Minimum Lumen Diameter In-segment After Stent Implantation | 2.1 mm | Standard Deviation 0.3 |
| Rotational Atherectomy + Plain Old Balloon | Minimum Lumen Diameter In-segment After Stent Implantation | 2.1 mm | Standard Deviation 0.4 |
Secondary
Minimum Lumen Diameter In-stent After Stent Implantation
Minimum lumen diameter in-stent after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Minimum Lumen Diameter In-stent After Stent Implantation | 2.5 mm | Standard Deviation 0.3 |
| Rotational Atherectomy + Plain Old Balloon | Minimum Lumen Diameter In-stent After Stent Implantation | 2.5 mm | Standard Deviation 0.4 |
Secondary
Minimum Percent Stent Expansion After Percutaneous Coronary Intervention
Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Minimum Percent Stent Expansion After Percutaneous Coronary Intervention | 86.1 minimum percent expansion | Standard Deviation 17.5 |
| Rotational Atherectomy + Plain Old Balloon | Minimum Percent Stent Expansion After Percutaneous Coronary Intervention | 78.6 minimum percent expansion | Standard Deviation 14.7 |
Secondary
Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention
Cardiac Death
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention
Non-Cardiac Death
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With a Balloon Rupture
Device problem; Rupture of the cutting balloon or plain old balloon
Time frame: Post-Procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With a Balloon Rupture | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With a Balloon Rupture | 0 Participants |
Secondary
Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon
Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area.
Time frame: Post-Procedure, Day 0
Population: one participant missing imaging for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon | 14 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon | 7 Participants |
Secondary
Number of Participants With Blade Detachment
Device problem; detachment of a blade from the cutting balloon
Time frame: Post-Procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Blade Detachment | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Blade Detachment | 0 Participants |
Secondary
Number of Participants With Difficulty in Withdrawing/Advancing the Device
Device problem; difficulty in moving the balloon within the vessel during the procedure
Time frame: Post-Procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Difficulty in Withdrawing/Advancing the Device | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Difficulty in Withdrawing/Advancing the Device | 0 Participants |
Secondary
Number of Participants With Dissection After Percutaneous Coronary Intervention
Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Dissection After Percutaneous Coronary Intervention | 1 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Dissection After Percutaneous Coronary Intervention | 3 Participants |
Secondary
Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)
Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall
Time frame: Post-CBA/NCBA before stent, Day 0
Population: one participant missing imaging for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA) | 27 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA) | 30 Participants |
Secondary
Number of Participants With Dissection Type B or Greater
Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography.
Time frame: Post-CBA/NCBA before stent and after stent, Day 0
Population: three participants missing imaging for this outcome measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Dissection Type B or Greater | Post-CBA/NCBA before stent | 6 Participants |
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Dissection Type B or Greater | Post-CBA/NCBA after stent | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Dissection Type B or Greater | Post-CBA/NCBA before stent | 13 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Dissection Type B or Greater | Post-CBA/NCBA after stent | 1 Participants |
Secondary
Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention
Bleeding Academic Research Consortium (BARC) Type 3 1. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding 2. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision Type 5 1. Probable fatal bleeding 2. Definite fatal bleeding (overt or autopsy or imaging confirmation)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention
The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention | 1 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation
Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation | 0 Participants |
Secondary
Number of Participants With Side Branch Closure After Stent Implantation
Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Side Branch Closure After Stent Implantation | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Side Branch Closure After Stent Implantation | 0 Participants |
Secondary
Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention
Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall.
Time frame: Post-Procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention | 5 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention | 9 Participants |
Secondary
Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention
Stent Thrombosis
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention
Revascularization
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention | 1 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention
Revascularization
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention | 1 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Number of Participants With Vascular Complications After Percutaneous Coronary Intervention
Vascular complication
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Number of Participants With Vascular Complications After Percutaneous Coronary Intervention | 0 Participants |
| Rotational Atherectomy + Plain Old Balloon | Number of Participants With Vascular Complications After Percutaneous Coronary Intervention | 0 Participants |
Secondary
Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention
Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention | 26.9 percent of participants |
| Rotational Atherectomy + Plain Old Balloon | Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention | 13.2 percent of participants |
Secondary
Percent Residual Diameter Stenosis In-segment After Stent Implantation
Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Percent Residual Diameter Stenosis In-segment After Stent Implantation | 25.8 percent residual diameter stenosis | Standard Deviation 8.6 |
| Rotational Atherectomy + Plain Old Balloon | Percent Residual Diameter Stenosis In-segment After Stent Implantation | 28.4 percent residual diameter stenosis | Standard Deviation 6.8 |
Secondary
Percent Residual Diameter Stenosis In-stent After Stent Implantation
Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography
Time frame: Post-procedure, Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotational Atherectomy + Cutting Balloon | Percent Residual Diameter Stenosis In-stent After Stent Implantation | 13.8 percent residual diameter stenosis | Standard Deviation 6.5 |
| Rotational Atherectomy + Plain Old Balloon | Percent Residual Diameter Stenosis In-stent After Stent Implantation | 14.8 percent residual diameter stenosis | Standard Deviation 6.1 |