Status:
NOT_YET_RECRUITING
OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure
Lead Sponsor:
Albert Schweitzer Ziekenhuis, Netherlands
Collaborating Sponsors:
Meril Life Sciences Pvt. Ltd.
Angiocare BV, Netherlands
Conditions:
Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18+ years
Brief Summary
Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic...
Eligibility Criteria
Inclusion
- Stable coronary artery disease with one or more significant epicardial stenosis in native coronary arteries suitable for OCT or IVUS-guided PCI with BRS implantation.
- Subject must be at least 18 years of age
- Written consent to participate in the study
Exclusion
- Culprit lesions in the setting of acute coronary syndrome.
- Lesions with severe calcification.
- Lesions in a coronary artery with severe tortuosity.
- Left main coronary artery lesions.
- Bifurcation lesions.
- Ostial lesions.
- Lesions with a difference in proximal and distal reference diameter of \>0.5 mm by visual judgement of the coronary angiogram by the treating operator.
- Treatment of in-stent restenosis or stent thrombosis.
- History of definite stent thrombosis.
- Lesions in coronary artery bypass grafts.
- Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
- Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
- Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
- Planned non-deferrable major surgery after PCI.
- Known comorbidity associated with a life expectancy \<1 year.
- Unable to understand and follow study-related instructions or unable to comply with study protocol.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06919562
Start Date
September 1 2025
End Date
August 1 2030
Last Update
July 15 2025
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