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

NCT ID: NCT03074305

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2018-01-25

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.

Detailed Description

The bioresorbable vascular scaffold (BRS) has been emerged as new therapeutic option in percutaneous coronary intervention for coronary artery disease. Although 2nd generation drug-eluting stent (DES) has enhanced the efficacy and safety of DES, However, along with the widespread use of this newer generation DES in most clinical conditions, including high-risk patients with more complicated lesion profiles, ISR has continued to be a major concern, even in the era of newer generation DES. In this regards, the concept of BRS has introduced and has showed promising results. Nevertheless, previous reports showed that even BRS has not been free from restenosis, leading target lesion revascularization up to 7.4% during 3-year follow up. Currently, previous researches which comparedsafety and efficacy of treatment options for ISR lesion showed similar clinical outcomes following 2 representative options, namely, drug-eluting balloon or drug-eluting stent. In this regards, current European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) guidelines recommend drug-eluting balloon (DEB) and 2nd generation DES as class IA recommendations for the treatment of BMS or DES-ISR. However, all the previous reports evaluated the ISR of metallic stents, and there has been no evidence for treatment option for BRS ISR.

Therefore, the Smart Angioplasty Research Team: Safety and Efficacy of Drug-Eluting Balloon versus 2nd Generation Drug-Eluting Stent in Treatment of In-Bioresorbable Vascular Scaffold Restenosis (SMART-BRS-ISR) trial will randomly allocate patients with BRS ISR into DEB or 2nd generation DES and compare safety and efficacy of both treatment options.

Conditions

Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEB strategy

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

Group Type: ACTIVE_COMPARATOR

PCI for in-bioresorbable scaffold stenosis

Intervention Type: 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

DES strategy

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.

Group Type: ACTIVE_COMPARATOR

PCI for in-bioresorbable scaffold stenosis

Intervention Type: 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

Interventions

PCI for in-bioresorbable scaffold stenosis

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

1. Visual stenosis ≥50% in ISR segment with typical angina symptom (CCS class ≥II) or positive non-invasive stress tests

2. ISR lesion with fractional flow reserve (FFR) ≤0.80

3. 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joo-Yong Hahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joo-Yong Hahn, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BRS-ISR16453143

Identifier Type: -

Identifier Source: org_study_id