- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074305
DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold (SMART-BRS-ISR)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
- 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
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
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.
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In patients who have in-bioresorbable scaffold stenosis after bioresorbable scaffold implantation, PCI will performed according to the allocated arms
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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.
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In patients who have in-bioresorbable scaffold stenosis after bioresorbable scaffold implantation, PCI will performed according to the allocated arms
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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
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13-month after index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-PCI FFR value
Time Frame: Immediate after index procedure
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Immediate after index procedure
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post-PCI MLD
Time Frame: Immediate after index procedure
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Immediate after index procedure
|
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minimum stent area (MSA) measured by intravascular ultrasound (IVUS)
Time Frame: Immediate after index procedure
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Immediate after index procedure
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minimum stent area measured by optical coherence tomography (OCT)
Time Frame: Immediate after index procedure
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Immediate after index procedure
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follow-up FFR
Time Frame: 13-month after index procedure
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13-month after index procedure
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13-month follow-up minimal stent area measured by IVUS or OCT
Time Frame: 13-month after index procedure
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stratified analysis according to imaging modality
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13-month after index procedure
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OCT findings in neoatherosclerotic tissue
Time Frame: 13-month after index procedure
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macrophage infiltration, presence of thin-cap fibrous neoatheroma (TCNA), patterns of neoatherosclerotic tissue (homogeneous, heterogeneous, layered, neoatherosclrotic), cap thickness
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13-month after index procedure
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All-cause mortality
Time Frame: 12-month after index procedure
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12-month after index procedure
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Cardiac death
Time Frame: 12-month after index procedure
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12-month after index procedure
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Any myocardial infarction
Time Frame: 12-month after index procedure
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12-month after index procedure
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12-month follow up any revascularization
Time Frame: 12-month after index procedure
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12-month after index procedure
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Target vessel revascularization
Time Frame: 12-month after index procedure
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12-month after index procedure
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Stent thrombosis
Time Frame: 12-month after index procedure
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12-month after index procedure
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Major adverse cardiovascular events
Time Frame: 12-month after index procedure
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a composite of cardiac death, target-vessel MI, and target lesion revascularization
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12-month after index procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Joo-Yong Hahn, MD, PhD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRS-ISR16453143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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