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

NCT06919562 | Not Yet Recruiting

• 2 other identifiers: PERFECT RESTORENL-009177
• Study Type: observational
• Target: 117
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Minimal scaffold area

  End of procedure

• Scaffold malapposition

  End of procedure

• Scaffold expansion

  End of procedure

• Edge dissection

  End of procedure

• Intra-scaffold plaque protrusion and thrombus

  End of procedure

Interventions

Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging PROCEDURE

Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with obstructive stable coronary artery disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Schweitzer Ziekenhuis, Netherlands: lead
• Meril Life Sciences Pvt. Ltd.: collaborator
• Angiocare BV, Netherlands: collaborator
• Salveo Medical BV, Netherlands: collaborator

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Jin M. Cheng, MD, PhD

CONTACT

+31786541492; j.m.cheng@asz.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share