Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

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.
    

Intervention name(s): Excimer Laser Coronary Atherectomy
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): ELCA Coronary Laser Atherectomy Catheters (OTW and RX)
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ELCA; Coronary Artery Disease; India