Clinical trial NCT03284229: Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: ELCA
Coronary Artery Disease
India
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: CBCC-VIBGYOR Research Pvt. Ltd.
First posted: 2017-09-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
timeFrame: Procedure
measure: Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
timeFrame: Procedure
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: TIMI Flow
timeFrame: pre-procedure and post-procedure
measure: Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
timeFrame: Procedure
measure: Lesion Morphology - Eccentricity of Coronary Lesion
timeFrame: Procedure
measure: Lesion Morphology - Contour as a Lesion Characteristic
timeFrame: Procedure
measure: Lesion Morphology - Bifurcation (Branch or Division of Artery)
timeFrame: Procedure
measure: Participants With Device-related Complications During Procedure
timeFrame: Procedure
measure: Participants With Procedure-related Complications During Procedure
timeFrame: Procedure
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre Limited
state: Delhi
city: New Delhi
country: India
facility: All Indian Institute of Medical Sciences (AIIMS)
state: Delhi
city: Gurgaon
country: India
facility: Global Health Private Limited, Medanta - The Medicity
state: Haryana
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences and Research
state: Karnataka
city: Bandra
country: India
facility: Lilavati Hospital and Research Centre
state: Mumbai
Study officials:
affiliation: Spectranetics Corporation
name: Karen Krygier, MBA
role: STUDY_DIRECTOR
References: