Status:
COMPLETED
Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD
Lead Sponsor:
Spectranetics Corporation
Collaborating Sponsors:
CBCC-VIBGYOR Research Pvt. Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 Ar...
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 assi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03284229
Start Date
September 20 2017
End Date
May 21 2018
Last Update
September 18 2020
Active Locations (5)
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1
Global Health Private Limited, Medanta - The Medicity
Gurgaon, Haryana, India, 122001
2
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, India, 560069
3
Lilavati Hospital and Research Centre
Bāndra, Mumbai, India, 100050
4
Escorts Heart Institute & Research Centre Limited
New Delhi, National Capital Territory of Delhi, India, 160011