Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Heart Diseases, Myocardial Ischemia
Conditions
Brief summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Interventions
DEVICESapphire II PRO
To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.
Sponsors
Icahn School of Medicine at Mount Sinai
OrbusNeich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. 4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria 5. Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure. 6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 7. Target and non-target lesions must be located in different coronary arteries or bypass grafts. 8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO) 9. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success. Clinical
Exclusion criteria
1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. 2. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure. 3. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure. 4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 5. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure. 6. Cerebrovascular accident (CVA) within the past 6 months. 7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 8. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Procedural Success | Peri-procedural (at Day 0) | Device procedural success consisting of the following: * Successful delivery, inflation, deflation and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | Endpoints will be measured through hospital discharge (expected to be within 24 hours) | In-hospital Major Adverse Cardiac Events (MACE) * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR) |
| Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | In-hospital stent thrombosis (ST) within the target vessel |
| Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | Clinically Significant Arrhythmias (requiring intervention) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sapphire II PRO Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Sapphire II PRO |
|---|---|
| Age, Continuous | 67.26 Years STANDARD_DEVIATION 9.35 |
| Cardiac History Previous Coronary Artery Bypass Graft | 18 Participants |
| Cardiac History Previous Myocardial Infarction | 25 Participants |
| Cardiac History Previous Percutaneous Coronary Intervention | 31 Participants |
| Cardiac History Stable Angina | 31 Participants |
| Cardiac History Unstable Angina | 21 Participants |
| Cardiac Risk Factors Current Cigarette Smoking (within 30 days) | 10 Participants |
| Cardiac Risk Factors Hypercholesterolemia Requiring Treatment | 55 Participants |
| Cardiac Risk Factors Hypertension Requiring Treatment | 51 Participants |
| Cardiac Risk Factors Medically Treated Diabetes | 16 Participants |
| Lesion Characteristics Aneurysm | 0 Lesions |
| Lesion Characteristics Calcification | 34 Lesions |
| Lesion Characteristics Lesion Length | 18.42 Millimeters STANDARD_DEVIATION 12.25 |
| Lesion Characteristics Minimum Lumen Diameter | .52 Millimeters STANDARD_DEVIATION 0.35 |
| Lesion Characteristics Thrombus | 1 Lesions |
| Lesion Characteristics Tortuosity | 0 Lesions |
| Lesion Characteristics Total Occlusion | 9 Lesions |
| Lesion Characteristics Ulceration | 4 Lesions |
| Lesion Characteristics: Lesion Location Distal | 11 Lesions |
| Lesion Characteristics: Lesion Location Mid | 27 Lesions |
| Lesion Characteristics: Lesion Location Ostial | 3 Lesions |
| Lesion Characteristics: Lesion Location Prox | 26 Lesions |
| Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 0 (no perfusion) | 9 Lesions |
| Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 1 (penetration with minimal perfusion) | 4 Lesions |
| Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 2 (partial perfusion) | 4 Lesions |
| Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 3 (complete perfusion) | 50 Lesions |
| Lesion Characteristics: Vessel Treated Bypass Graft | 4 Lesions |
| Lesion Characteristics: Vessel Treated Diagonol Branch-Left Anterior Descending Artery | 10 Lesions |
| Lesion Characteristics: Vessel Treated Left Anterior Descending Artery | 22 Lesions |
| Lesion Characteristics: Vessel Treated Left Circumflex Artery | 12 Lesions |
| Lesion Characteristics: Vessel Treated Marginal Branch of Left Circumflex Artery | 1 Lesions |
| Lesion Characteristics: Vessel Treated Posterior Descending Branch-Right Coronary Artery | 2 Lesions |
| Lesion Characteristics: Vessel Treated Right Coronary Artery | 16 Lesions |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized White | 57 Participants |
| Region of Enrollment United States | 61 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 1 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
Number of Participants With Device Procedural Success
Device procedural success consisting of the following: * Successful delivery, inflation, deflation and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure
Time frame: Peri-procedural (at Day 0)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sapphire II PRO | Number of Participants With Device Procedural Success | 59 Participants |
Secondary
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
Clinically Significant Arrhythmias (requiring intervention)
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sapphire II PRO | Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | 0 Participants |
Secondary
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
In-hospital Major Adverse Cardiac Events (MACE) * All death (cardiac and non-cardiac) * Myocardial infarction (MI) * Target Lesion Revascularization (TLR)
Time frame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sapphire II PRO | Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 1 Participants |
Secondary
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
In-hospital stent thrombosis (ST) within the target vessel
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Population: Analysis population consists of intent-to-treat subject population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sapphire II PRO | Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | 0 Participants |