DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold (SMART-BRS-ISR)

November 24, 2023 updated by: Joo-Yong Hahn, Samsung Medical Center

Randomized Controlled Trial for Comparison of Efficacy and Safety Between Drug-eluting Balloon and 2nd Generation Drug-Eluting Stent in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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

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
Active Comparator: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI
Time Frame: 13-month after index procedure
13-month after index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Joo-Yong Hahn, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

December 18, 2017

Study Completion (Estimated)

December 18, 2023

Study Registration Dates

First Submitted

March 4, 2017

First Submitted That Met QC Criteria

March 4, 2017

First Posted (Actual)

March 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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