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 (PERFECTRESTORE)

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 PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention (PCI); Coronary Arterial Disease (CAD)
• Intervention / Treatment: Procedure: Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging

• Study Type: Observational
• Enrollment (Estimated): 117

Contacts and Locations

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

Study Locations

• Netherlands
  • Dordrecht, Netherlands
    • Recruiting
    • Albert Schweitzer Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with obstructive stable coronary artery disease

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion.	End of procedure
Angiographic success	Percentage of angiographic success, defined as <10% residual stenosis and TIMI 3 flow.	End of procedure
Treatment protocol adherence	Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure.	End of procedure
Optimal scaffold result	Percentage of optimal scaffold result on intracoronary imaging, defined as no major edge dissection, no major malexpansion and scaffold expansion >90%.	End of procedure
Additional optimization steps	Percentage of additional optimization steps (including additional postdilatation, additional BRS implantation, bailout metallic DES implantation, additional intracoronary imaging) to achieve optimal scaffold result.	End of procedure
Target Lesion Failure	Estimate of target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization	1-year and 3-year post-procedure
Scaffold thrombosis	Estimate of scaffold thrombosis	1-year and 3-year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal scaffold area	Minimal scaffold area assessed with the final OCT or IVUS measurement	End of procedure
Scaffold malapposition	Scaffold malapposition as percentage, defined as frequency of incompletely apposed struts (i.e. struts clearly separated from the vessel wall without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch) assessed with the final OCT or IVUS measurement.	End of procedure
Scaffold expansion	Scaffold expansion as percentage, defined as scaffold area divided by the average of proximal and distal reference lumen areas, assessed with the final OCT or IVUS measurement.	End of procedure
Edge dissection	Presence of edge dissection assessed with the final OCT or IVUS measurement.	End of procedure
Intra-scaffold plaque protrusion and thrombus	Intra-scaffold plaque protrusion and thrombus, defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut, assessed with the final OCT or IVUS measurement.	End of procedure

Collaborators and Investigators

• Sponsor: Albert Schweitzer Ziekenhuis, Netherlands
• Collaborators: Meril Life Sciences Pvt. Ltd.; Angiocare BV, Netherlands; Salveo Medical BV, Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: PERFECT RESTORE; NL-009177 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No