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Recruiting 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

— Observational Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
    Percutaneous coronary intervention (PCI) with implantation of the MeRes100 thin-strut BRS with protocolized PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance.

Primary outcome measures

  • Technical success [Time frame: End of procedure]
  • Angiographic success [Time frame: End of procedure]
  • Treatment protocol adherence [Time frame: End of procedure]
  • Optimal scaffold result [Time frame: End of procedure]
  • Additional optimization steps [Time frame: End of procedure]
  • Target Lesion Failure [Time frame: 1-year and 3-year post-procedure]
  • Scaffold thrombosis [Time frame: 1-year and 3-year post-procedure]
Secondary outcome measures (5)
  • Minimal scaffold area [Time frame: End of procedure]
  • Scaffold malapposition [Time frame: End of procedure]
  • Scaffold expansion [Time frame: End of procedure]
  • Edge dissection [Time frame: End of procedure]
  • Intra-scaffold plaque protrusion and thrombus [Time frame: End of procedure]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Albert Schweitzer ziekenhuis — Dordrecht

Identifiers

NCT: NCT06919562 · PERFECT RESTORE · NL-009177

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗