DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold

NCT03074305 | Withdrawn DMC

• 1 other identifier: BRS-ISR16453143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare angiographic outcomes following revascularization using drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of Bioresorbable Vascular Scaffold Restenosis.

Conditions

Coronary Artery Disease; Coronary Restenosis

Keywords

In-bioresorbable vascular scaffold restenosis; drug-eluting stent; drug-eluting balloon; bioresorbable scaffold

Outcome Measures

Primary Outcomes (1)

• Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI

  13-month after index procedure

Secondary Outcomes (14)

• post-PCI FFR value

  Immediate after index procedure

• post-PCI MLD

  Immediate after index procedure

• minimum stent area (MSA) measured by intravascular ultrasound (IVUS)

  Immediate after index procedure

• minimum stent area measured by optical coherence tomography (OCT)

  Immediate after index procedure

• follow-up FFR

  13-month after index procedure

Study Arms (2)

DEB strategy

ACTIVE COMPARATOR

DEB procedure will be standardized in order to maximize drug delivery into target segment. Commercially available DEB will be used (Sequent Please, B Braun, Germany or Pantera Lux, Biotronik, German). The below requirements will be mandatorily recommended. 1. Residual stenosis after lesion preparation : %DS \<20% 2. Delivery time : \< 30 seconds 3. Total inflation time : \> at least 1 minute 4. Previous BVS : DEB diameter ratio : \> 1.0:1 5. Maximum inflation pressure : at least above nominal pressure of DEB

Device: PCI for in-bioresorbable scaffold stenosis

DES strategy

ACTIVE COMPARATOR

The implantation of 2nd generation DES will be performed as universally recommended. In the DES group, the newest version of 2nd generation everolimus-eluting stent (Xience Alpine, Abbott Vascular, USA) will be recommended.

Device: PCI for in-bioresorbable scaffold stenosis

Interventions

PCI for in-bioresorbable scaffold stenosis DEVICE

In patients who have in-bioresorbable scaffold stenosis after bioresorbable scaffold implantation, PCI will performed according to the allocated arms 1. DEB strategy 2. DES strategy

DEB strategy; DES strategy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age 19-85 years old
• Patients with BRS ISR and presented with angina symptom or objective sign of inducible myocardial ischemia (one of the followings)
• Visual stenosis ≥50% in ISR segment with typical angina symptom (CCS class ≥II) or positive non-invasive stress tests
• ISR lesion with fractional flow reserve (FFR) ≤0.80
• Visual stenosis ≥70% in ISR segment (in the absence of above 2 components)
• Patients with BRS ISR which can be treated by DEB angioplasty or second generation DES implantation

You may not qualify if:

• Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
• Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
• Patients with active bleeding or history of gastrointestinal or genitourinary major bleeding within 3-month
• Chronic kidney disease (serum creatinine ≥2.0mg/dL or estimated glomerular filtration rate \<30ml/min)
• Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
• Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• In-segment edge restenosis without definite involvement of previous BRS edge
• Unwillingness or inability to comply with the procedures described in this protocol.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: March 4, 2017
• First Posted: March 8, 2017
• Study Start: March 8, 2017
• Primary Completion: December 30, 2017
• Study Completion: January 25, 2018
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)