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Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD (ELCA-CAD)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Excimer Laser Coronary Atherectomy
Sponsored by
Spectranetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring ELCA, Coronary Artery Disease, India

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Escorts Heart Institute & Research Centre Limited
  • All Indian Institute of Medical Sciences (AIIMS)
  • Global Health Private Limited, Medanta - The Medicity
  • Sri Jayadeva Institute of Cardiovascular Sciences and Research
  • Lilavati Hospital and Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Excimer Laser Coronary Atherectomy

Arm Description

ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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.
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Tortuosity from coronary angiography
Lesion Morphology - Eccentricity of Coronary Lesion
Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
Lesion Morphology - Contour as a Lesion Characteristic
Contour from coronary angiography
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Bifurcation from coronary angiography
Participants With Device-related Complications During Procedure
To determine device related complications
Participants With Procedure-related Complications During Procedure
To determine procedure related complications

Full Information

First Posted
September 8, 2017
Last Updated
September 16, 2020
Sponsor
Spectranetics Corporation
Collaborators
CBCC-VIBGYOR Research Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03284229
Brief Title
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
Acronym
ELCA-CAD
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
May 21, 2018 (Actual)
Study Completion Date
May 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation
Collaborators
CBCC-VIBGYOR Research Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
ELCA, Coronary Artery Disease, India

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Excimer Laser Coronary Atherectomy
Arm Type
Experimental
Arm Description
ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted.
Intervention Type
Device
Intervention Name(s)
Excimer Laser Coronary Atherectomy
Other Intervention Name(s)
ELCA Coronary Laser Atherectomy Catheters (OTW and RX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
Description
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Time Frame
Procedure
Title
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Description
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
Time Frame
Procedure
Title
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
Description
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
Secondary Outcome Measure Information:
Title
TIMI Flow
Description
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
Title
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Description
Tortuosity from coronary angiography
Time Frame
Procedure
Title
Lesion Morphology - Eccentricity of Coronary Lesion
Description
Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
Time Frame
Procedure
Title
Lesion Morphology - Contour as a Lesion Characteristic
Description
Contour from coronary angiography
Time Frame
Procedure
Title
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Description
Bifurcation from coronary angiography
Time Frame
Procedure
Title
Participants With Device-related Complications During Procedure
Description
To determine device related complications
Time Frame
Procedure
Title
Participants With Procedure-related Complications During Procedure
Description
To determine procedure related complications
Time Frame
Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Krygier, MBA
Organizational Affiliation
Spectranetics Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Escorts Heart Institute & Research Centre Limited
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
160011
Country
India
Facility Name
All Indian Institute of Medical Sciences (AIIMS)
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
Global Health Private Limited, Medanta - The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Sri Jayadeva Institute of Cardiovascular Sciences and Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560069
Country
India
Facility Name
Lilavati Hospital and Research Centre
City
Bandra
State/Province
Mumbai
ZIP/Postal Code
100050
Country
India

12. IPD Sharing Statement

Links:
URL
http://www.spectranetics.com/resources/ifu-library/
Description
ELCA laser system and catheter IFUs

Learn more about this trial

Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD

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