Status:
COMPLETED
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia
Lead Sponsor:
InnoRa GmbH
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
Detailed Description
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental ...
Eligibility Criteria
Inclusion
- Clinical evidence of stable or unstable angina or a positive functional study
- Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
- Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)
Exclusion
- Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
- Intolerance and / or allergy to Sirolimus
- Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:
- iopromide)
- Patients with an ejection fraction of \< 30 %
- Reference vessel diameter (RVD) \< 2.5 mm
- Contraindication for whichever necessary accompanying medication
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04017364
Start Date
July 1 2019
End Date
January 31 2021
Last Update
August 27 2021
Active Locations (6)
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1
Sabah Heart Centre, Queen Elizabeth Hospital II
Kota Kinabalu, Malaysia, 88300
2
National Heart Institute
Kuala Lumpur, Malaysia, 50400
3
Cardio Vascular Sentral
Kuala Lumpur, Malaysia, 50470
4
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50603