Clinical study to asses the CT angiography results following the use of the MeRes100 Sirolimus-Eluting Bioresorbable Vascular Scaffold System in patients with coronary artery disease.
Phase 4
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2024/04/066128
- Lead Sponsor
- Dr Keyur Parikh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patient who has been implanted with MeRes100 BRS from February 2021 to March 2023.
2. Patient has given written informed consent for participation prior to enrolment.
3. Patient is willing to undergo all study procedures and follow-up requirements.
Exclusion Criteria
1. Any condition, which in the Investigator’s opinion would preclude safe participation of patient in the study.
2. Patient participating in another clinical investigation.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area stenosis: <br/ ><br>Area stenosis is calculated as the reference minus the minimal lumen area as a percentage of the reference lumen area. The reference vessel lumen area is calculated as the average of the mean proximal and mean distal vessel areasTimepoint: Mean Follow up <br/ ><br>The study will prospectively assess outcomes of patients implanted with MeRes100 BRS from Feb 2021 to Mar 2023. CT angiography will be conducted with patient consent, at least one year post-procedure. Mean follow-up is defined as the timeframe for assessing CT outcomes
- Secondary Outcome Measures
Name Time Method