Coronary Artery Disease
Conditions
Keywords
ELCA, Coronary Artery Disease, India
Brief summary
This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05 Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints at the study centre.
Detailed description
Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints. Upon enrollment after obtaining a written informed consent, each patient will be assigned a unique identification number. Only patients eligible to undergo cardiac catheterizations as per routine practice will be considered for the study. Premedication of patients will be as per the investigator's routine practice. All patient data will be recorded on patient data forms. Screening: This will be performed prior to the cardiac catheterization procedure. Only patients who have consented and fulfill the selection criteria will be enrolled. Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusion/exclusion criteria. Procedure: The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU. Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification, AE assessments, concomitant medications and any coronary intervention that has occurred since the previous contact. An electrocardiogram (ECG) will be repeated during the clinic visit.
Interventions
DEVICEExcimer Laser Coronary Atherectomy
Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.
Sponsors
CBCC-VIBGYOR Research Pvt. Ltd.
Spectranetics Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
As per the 25th SEC (Cardiovascular & Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have at least one severely stenotic lesion (greater than or equal to 80% diameter stenosis as assessed by visual estimation) * Haemodynamically stable patients coming to the site for cardiac catheterization and angiography for various indications and who fulfill all the following criteria: * Have no clinically significant cardiac arrhythmias, based on ECG results * Have no evidence of valvular pathology, based on echocardiogram results * Have ≥30% left ventricular ejection fraction (LVEF), based on echocardiogram results. * Angiographic evidence of calcification or a chronic total occlusion * Vessel reference diameter greater than or equal to 2.0 mm * Patient is willing and able to comply with study requirements * Women of child bearing potential, willing to use at least two methods of contraception
Exclusion criteria
* Evidence of acute coronary syndrome within 3 months prior to index procedure * Evidence of acute ischemic events * Cardiogenic and non-cardiogenic shock * Active bleeding or coagulopathy * Previous coronary angioplasty within 6 months of the index procedure * Patients participating in trial for another investigational device/medicine within 1 month prior to enrolment in this study * Acute or Chronic renal failure, Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 umol/l) determined within 72 hours prior to index procedure. * Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal * Planned surgery within 6 months of enrollment in this study * Life expectancy less than 6 months * Patients known to be suffering from substance abuse (alcohol or drug) * Patients with any other significant co-morbid illness which in the opinion of the investigator is not conducive of inclusion in the study. * Known or suspected Pregnancy * Patients not willing to provide written informed consent * In the investigators opinion subjects will not be able to comply with the follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion | Procedure | Successful crossing of the Laser Catheter across the entire length of the stenotic lesion |
| Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure | Procedure | Target lesions with less than 50% residual stenosis after laser and adjunctive therapy. |
| Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | 30 days | Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Morphology - Contour as a Lesion Characteristic | Procedure | Contour from coronary angiography |
| Lesion Morphology - Bifurcation (Branch or Division of Artery) | Procedure | Bifurcation from coronary angiography |
| TIMI Flow | pre-procedure and post-procedure | To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow. TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below. * TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. * TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. * TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. * TIMI 3 is normal flow which fills the distal coronary bed completely. |
| Participants With Procedure-related Complications During Procedure | Procedure | To determine procedure related complications |
| Participants With Device-related Complications During Procedure | Procedure | To determine device related complications |
| Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity | Procedure | Tortuosity from coronary angiography |
| Lesion Morphology - Eccentricity of Coronary Lesion | Procedure | Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric) |
Countries
India
Participant flow
Pre-assignment details
31 patients were screened. 3 patients were screen failure. 28 patients enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Enrolled Patients | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Enrolled | — |
|---|---|---|
| Age, Continuous | 64.04 years STANDARD_DEVIATION 8.26 | — |
| Angina Class Class 0/I | 3 Participants | — |
| Angina Class Class II | 17 Participants | — |
| Angina Class Class III | 4 Participants | — |
| Angina Class Class IV | 1 Participants | — |
| Height | 163.50 cms STANDARD_DEVIATION 8.68 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 25 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
| Weight | 70.80 kgs STANDARD_DEVIATION 11.37 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 3 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion | Success | 25 Participants |
| Enrolled | Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion | Failure | 0 Participants |
Primary
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure | < 50% | 25 Participants |
| Enrolled | Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure | ≥ 50% | 0 Participants |
Primary
Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias
Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.
Time frame: 30 days
Population: Safety success includes 25 subjects that completed follow up and 3 subjects that were Lost To Follow Up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Cardiac Tamponade | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Death | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Non-Q-wave | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Q-wave myocardial infarction | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Target Lesion Revascularization | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | Life threatening arrhythmias | 0 Participants |
| Enrolled | Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias | No Major Adverse Cardiac Events | 28 Participants |
Secondary
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Bifurcation from coronary angiography
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Lesion Morphology - Bifurcation (Branch or Division of Artery) | Bifurcation | 0 Participants |
| Enrolled | Lesion Morphology - Bifurcation (Branch or Division of Artery) | No Bifurcation | 25 Participants |
Secondary
Lesion Morphology - Contour as a Lesion Characteristic
Contour from coronary angiography
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Lesion Morphology - Contour as a Lesion Characteristic | Irregular Contour | 20 Participants |
| Enrolled | Lesion Morphology - Contour as a Lesion Characteristic | Smooth Contour | 5 Participants |
Secondary
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Tortuosity from coronary angiography
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity | < 45° | 14 Participants |
| Enrolled | Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity | 45° - 90° | 8 Participants |
| Enrolled | Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity | > 90° | 3 Participants |
Secondary
Lesion Morphology - Eccentricity of Coronary Lesion
Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Lesion Morphology - Eccentricity of Coronary Lesion | Concentric lesions | 17 Participants |
| Enrolled | Lesion Morphology - Eccentricity of Coronary Lesion | Eccentric lesions | 8 Participants |
Secondary
Participants With Device-related Complications During Procedure
To determine device related complications
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Participants With Device-related Complications During Procedure | Yes | 0 Participants |
| Enrolled | Participants With Device-related Complications During Procedure | No | 25 Participants |
Secondary
Participants With Procedure-related Complications During Procedure
To determine procedure related complications
Time frame: Procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Participants With Procedure-related Complications During Procedure | Yes | 0 Participants |
| Enrolled | Participants With Procedure-related Complications During Procedure | No | 25 Participants |
Secondary
TIMI Flow
To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow. TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below. * TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. * TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. * TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. * TIMI 3 is normal flow which fills the distal coronary bed completely.
Time frame: pre-procedure and post-procedure
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enrolled | TIMI Flow | Pre-Procedure TIMI grade flow | TIMI grade flow 0 | 0 Participants |
| Enrolled | TIMI Flow | Pre-Procedure TIMI grade flow | TIMI grade flow 1 | 12 Participants |
| Enrolled | TIMI Flow | Pre-Procedure TIMI grade flow | TIMI grade flow 2 | 9 Participants |
| Enrolled | TIMI Flow | Pre-Procedure TIMI grade flow | TIMI grade flow 3 | 4 Participants |
| Enrolled | TIMI Flow | Post Procedure TIMI grade flow | TIMI grade flow 0 | 0 Participants |
| Enrolled | TIMI Flow | Post Procedure TIMI grade flow | TIMI grade flow 1 | 0 Participants |
| Enrolled | TIMI Flow | Post Procedure TIMI grade flow | TIMI grade flow 2 | 0 Participants |
| Enrolled | TIMI Flow | Post Procedure TIMI grade flow | TIMI grade flow 3 | 25 Participants |