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ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis

Not Applicable
Active, not recruiting
Conditions
Coronary Artery Lesion
Registration Number
NCT02486068
Lead Sponsor
European Cardiovascular Research Center
Brief Summary

The primary objectives of this trial are:

In patients at high-risk for restenosis,

* To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year

* To assess superiority of the BRS to the EES in TLF between 3 and 7 years

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1670
Inclusion Criteria

Patients (18-75 years old) with at least one of the followings:

  • High-risk characteristics for restenosis

    • Medically treated Diabetes (oral medication or insulin)
    • Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent
  • Complex target lesion

    • Single de-novo target lesion satisfying at least one of the following:
    • Lesion length >28 mm
    • Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
    • Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
    • Bifurcation with single stent strategy
Exclusion Criteria
  • Patients are excluded from this study if they have:

  • Age <18 years or >75 years

  • Known comorbidities which make patients unable to complete 7-years follow-up

  • Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy

  • Pregnant woman

  • Breastfeeding woman

  • Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material

  • Cardiogenic Shock (Killip >2)

  • PCI with implantation of stents/scaffolds within previous 30 days.

  • Active bleeding or coagulopathy or patients at chronic anticoagulation therapy

  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint

  • Renal insufficiency (GFR <45 ml/min)

  • Life expectancy < 7 years

  • Known non-adherence to DAPT

  • Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)

  • LVEF <30%

  • Patients at high bleeding risk who are not suitable for long-term DAPT

  • Following lesion characteristics:

    • Target lesion reference vessel diameter (RVD) < 2.5 and > 4 mm
    • STEMI with RVD of >3.5mm of the culprit target lesion
    • Target lesion with in-stent/scaffold thrombosis
    • Graft lesions as target lesions
    • Aorto-ostial lesion(s)
    • Left main lesion
    • Severe tortuosity of target vessel
    • In-scaffold restenosis
    • Bifurcation target lesion with intended 2 stent/scaffold strategy
  • Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)1 year

Composite of:

* Cardiac death

* Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI)

* Clinically Indicated Target lesion revascularization

Secondary Outcome Measures
NameTimeMethod
superiority of the Absorb to the Xience in TLF between 3 and 7 years5 years
Superiority of the Absorb to the Xience in TLF at 7 years7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year1 year

Trial Locations

Locations (43)

Cardiovascular Center Aalst OLV

🇧🇪

Aalst, Belgium

CHR Citadelle

🇧🇪

Leuven, Belgium

UZ Leuven

🇧🇪

Leuven, Belgium

University Hospital Brno

🇨🇿

Brno, Czechia

Cardiocentre, University Hospital Kralovske

🇨🇿

Prague, Czechia

Central Military Hospital

🇨🇿

Prague, Czechia

Clinique Rhône Durance

🇫🇷

Avignon, France

CHU Clermont-Ferrand

🇫🇷

Clermont-Ferrand, France

Hôpital Privé Jacques Cartier

🇫🇷

Massy, France

Clinique Saint-Hilaire

🇫🇷

Rouen, France

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Cardiovascular Center Aalst OLV
🇧🇪Aalst, Belgium

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