AzTrials
AzTrials

Coronary Arterial Disease (CAD)PERFECTRESTORENCT06919562

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

An observational study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Albert Schweitzer Ziekenhuis, Netherlands at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imaging
Type of treatment
Surgery or procedure
How many people
117 participants
Where
1 siteNetherlands
Study dates
4 Nov 2025to Aug 2030
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with obstructive stable coronary artery disease

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin M. Cheng, MD, PhD contact

+31786541492

j.m.cheng@asz.nl

Netherlands1 site, 1 recruiting

  • Albert Schweitzer ziekenhuis

    Dordrecht

    Recruiting

Other trials in Netherlands

About this study

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary intervention with protocolized implantation of a second generation thin-strut bioresorbable scaffold guided by intracoronary imagingProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success

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

    Measured: End of procedure

  2. Angiographic success

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

    Measured: End of procedure

  3. Treatment protocol adherence

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

    Measured: End of procedure

  4. Optimal scaffold result

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

    Measured: End of procedure

  5. 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.

    Measured: End of procedure

  6. 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

    Measured: 1-year and 3-year post-procedure

  7. Scaffold thrombosis

    Estimate of scaffold thrombosis

    Measured: 1-year and 3-year post-procedure

Secondary outcomes (5)

  1. Minimal scaffold area

    Minimal scaffold area assessed with the final OCT or IVUS measurement

    Measured: End of procedure

  2. 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.

    Measured: End of procedure

  3. 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.

    Measured: End of procedure

  4. Edge dissection

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

    Measured: End of procedure

  5. 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.

    Measured: End of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start4 Nov 2025
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
117 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919562
Sponsor's protocol ID
PERFECT RESTORE
Other IDs
NL-009177
Acronym
PERFECTRESTORE
Status last verified
May 2026
First submitted
2 Apr 2025
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by Albert Schweitzer Ziekenhuis, Netherlands at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin M. Cheng, MD, PhD (+31786541492, j.m.cheng@asz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success (time frame: End of procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06919562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in