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

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Study Start: 2015-09-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14
• Primary Completion: 2018-08-28
• Study Completion: 2024-09

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

Name	Time	Method
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

Name	Time	Method
superiority of the Absorb to the Xience in TLF between 3 and 7 years	5 years
Superiority of the Absorb to the Xience in TLF at 7 years	7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year	1 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

Scroll for more (33 remaining)