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

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease; Coronary Restenosis
• Interventions: Device: PCI for in-bioresorbable scaffold stenosis

• Registration Number: NCT03074305
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-04
• Study First Submitted QC: 2017-03-04
• Study Start: 2017-03-08
• Study First Posted: 2017-03-08
• Primary Completion: 2017-12-30
• Study Completion: 2018-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB strategy	PCI for in-bioresorbable scaffold stenosis	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
DES strategy	PCI for in-bioresorbable scaffold stenosis	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.

Primary Outcome Measures

Name	Time	Method
Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI	13-month after index procedure

Secondary Outcome Measures

Name	Time	Method
minimum stent area measured by optical coherence tomography (OCT)	Immediate after index procedure
follow-up FFR	13-month after index procedure
post-PCI MLD	Immediate after index procedure
minimum stent area (MSA) measured by intravascular ultrasound (IVUS)	Immediate after index procedure
post-PCI FFR value	Immediate after index procedure
13-month follow-up minimal stent area measured by IVUS or OCT	13-month after index procedure	stratified analysis according to imaging modality
Any myocardial infarction	12-month after index procedure
All-cause mortality	12-month after index procedure
Cardiac death	12-month after index procedure
Stent thrombosis	12-month after index procedure
OCT findings in neoatherosclerotic tissue	13-month after index procedure	macrophage infiltration, presence of thin-cap fibrous neoatheroma (TCNA), patterns of neoatherosclerotic tissue (homogeneous, heterogeneous, layered, neoatherosclrotic), cap thickness
Target vessel revascularization	12-month after index procedure
12-month follow up any revascularization	12-month after index procedure
Major adverse cardiovascular events	12-month after index procedure	a composite of cardiac death, target-vessel MI, and target lesion revascularization

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of