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

Coronary Artery Disease Clinical Trial

— SMART-BRS-ISR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03074305
• Other study ID #: BRS-ISR16453143
• Status: Withdrawn
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Restenosis

Intervention

Device:
• 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 DEB strategy DES strategy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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