Clinical trial NCT06919562: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Lead sponsor: Albert Schweitzer Ziekenhuis, Netherlands
Sponsor class: OTHER
Collaborators: name: Meril Life Sciences Pvt. Ltd.
name: Angiocare BV, Netherlands
name: Salveo Medical BV, Netherlands
First posted: 2025-04-09
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obstructive stable coronary artery disease

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 local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). The investigators hypothesize that combining the use of a second generation thin-strut BRS and a protocolized implantation technique with intracoronary imaging guidance leads to favourable clinical outcomes. The aim of this study is to evaluate clinical outcome after protocolized intracoronary imaging-guided PCI with implantation of a second generation thin-struts BRS.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject must be at least 18 years of age
3. Written consent to participate in the study

Exclusion Criteria:

1. Culprit lesions in the setting of acute coronary syndrome.
2. Lesions with severe calcification.
3. Lesions in a coronary artery with severe tortuosity.
4. Left main coronary artery lesions.
5. Bifurcation lesions.
6. Ostial lesions.
7. 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.
8. Treatment of in-stent restenosis or stent thrombosis.
9. History of definite stent thrombosis.
10. Lesions in coronary artery bypass grafts.
11. Lesions not suitable for OCT or IVUS catheter delivery and imaging, e.g. due to tortuosity or distal localisation.
12. Creatinine Clearance ≤ 30 ml/min/1.73 m2 as calculated by MDRD formula for estimated GFR.
13. Contraindication to dual antiplatelet therapy with aspirin and a P2Y12 inhibitor or (if indicated) NOAC and P2Y12 inhibitor.
14. Planned non-deferrable major surgery after PCI.
15. Known comorbidity associated with a life expectancy \<1 year.
16. Unable to understand and follow study-related instructions or unable to comply with study protocol.

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 1-year and 3-year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: