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

European Cardiovascular Research Institute (ECRI)

Status: Active, not recruiting

Conditions: Coronary Artery Lesion

Treatments: Device: ABSORB scaffold; Device: Xience

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02486068

COMPARE ABSORB

Details and patient eligibility

About

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

Enrollment: 1,670 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,670 participants in 2 patient groups

ABSORB scaffold

Experimental group

Description:

Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.

Treatment:

Device: ABSORB scaffold

Xience

Active Comparator group

Description:

Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.

Treatment:

Device: Xience