Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Technical success

    Time frame: End of procedure

    Percentage of technical success, defined as successful implantation of the BRS in the obstructive coronary lesion.

  2. Angiographic success

    Time frame: End of procedure

    Percentage of angiographic success, defined as <10% residual stenosis and TIMI 3 flow.

  3. Treatment protocol adherence

    Time frame: End of procedure

    Percentage of treatment protocol adherence, defined as full completion of all PSP and intracoronary imaging steps during implantation procedure.

  4. Optimal scaffold result

    Time frame: End of procedure

    Percentage of optimal scaffold result on intracoronary imaging, defined as no major edge dissection, no major malexpansion and scaffold expansion >90%.

  5. Additional optimization steps

    Time frame: End of procedure

    Percentage of additional optimization steps (including additional postdilatation, additional BRS implantation, bailout metallic DES implantation, additional intracoronary imaging) to achieve optimal scaffold result.

  6. Target Lesion Failure

    Time frame: 1-year and 3-year post-procedure

    Estimate of target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization

  7. Scaffold thrombosis

    Time frame: 1-year and 3-year post-procedure

    Estimate of scaffold thrombosis

Secondary outcomes

  1. Minimal scaffold area

    Time frame: End of procedure

    Minimal scaffold area assessed with the final OCT or IVUS measurement

  2. Scaffold malapposition

    Time frame: End of procedure

    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.

  3. Scaffold expansion

    Time frame: End of procedure

    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.

  4. Edge dissection

    Time frame: End of procedure

    Presence of edge dissection assessed with the final OCT or IVUS measurement.

  5. Intra-scaffold plaque protrusion and thrombus

    Time frame: End of procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin M. Cheng, MD, PhD

CONTACT

[email protected]

+31786541492

Sponsors and collaborators

Lead sponsor

Albert Schweitzer Ziekenhuis, Netherlands

Other

Collaborators

  • Angiocare BV, Netherlands
  • Meril Life Sciences Pvt. Ltd.
  • Salveo Medical BV, Netherlands

Registry information

Acronym: PERFECTRESTORE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 9, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.