Clinical Trials Logo
NCT number NCT03284229
Study type Interventional
Source Spectranetics Corporation
Contact Julie Wolfram Smith, PhD, MBA
Phone 719-629-6642
Email julie.wolframsmith@spnc.com
Status Not yet recruiting
Phase N/A
Start date September 2017
Completion date December 2018

Clinical Trial 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.


Clinical Trial 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.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Not yet recruiting NCT03259815 - How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? N/A
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03231527 - Outcomes of Total Arterial Coronary Artery Bypass Grafting N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography) N/A
Not yet recruiting NCT03252990 - 18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability N/A
Not yet recruiting NCT02252783 - BFPET for Regional Myocardial Perfusion Imaging Phase 2
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT02693158 - The Direct III Post Market Study N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A
Terminated NCT02739685 - Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion Phase 4
Completed NCT03025685 - "Radial Ultra Support Technique" (RUS Technique) N/A
Not yet recruiting NCT02863952 - Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI N/A