Optimal stent deployment strategy for thinner-strut bioresorbable scaffolds guided by intracoronary imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry evaluates a second-generation, thin-strut bioresorbable scaffold implanted with a protocolized PSP approach and guided by intracoronary imaging (OCT or IVUS). Eligible adults with stable coronary artery disease and a significant native lesion undergo PCI using the imaging-guided strategy to optimize scaffold deployment. The study collects procedural and outcome data to see if this approach reduces complications and improves vessel healing compared with traditional DES-based PCI. Key elements include strict imaging guidance, detailed sizing, and post-dilatation, while exclusions address complex anatomy and renal impairment. Results will inform whether thinner-strut BRS with intracoronary imaging can address limitations seen with first-generation BRS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Albert Schweitzer ziekenhuis
  Dordrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Jin M. Cheng, MD, PhD
• Email: j.m.cheng@asz.nl
• Phone: +31786541492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.