Clinical trial NCT03074305: DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Restenosis
Keywords: In-bioresorbable vascular scaffold restenosis
drug-eluting stent
drug-eluting balloon
bioresorbable scaffold
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open label, two-arm, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI
timeFrame: 13-month after index procedure
Secondary outcomes:
measure: post-PCI FFR value
timeFrame: Immediate after index procedure
measure: post-PCI MLD
timeFrame: Immediate after index procedure
measure: minimum stent area (MSA) measured by intravascular ultrasound (IVUS)
timeFrame: Immediate after index procedure
measure: minimum stent area measured by optical coherence tomography (OCT)
timeFrame: Immediate after index procedure
measure: follow-up FFR
timeFrame: 13-month after index procedure
measure: 13-month follow-up minimal stent area measured by IVUS or OCT
timeFrame: 13-month after index procedure
measure: OCT findings in neoatherosclerotic tissue
timeFrame: 13-month after index procedure
measure: All-cause mortality
timeFrame: 12-month after index procedure
measure: Cardiac death
timeFrame: 12-month after index procedure
measure: Any myocardial infarction
timeFrame: 12-month after index procedure
measure: 12-month follow up any revascularization
timeFrame: 12-month after index procedure
measure: Target vessel revascularization
timeFrame: 12-month after index procedure
measure: Stent thrombosis
timeFrame: 12-month after index procedure
measure: Major adverse cardiovascular events
timeFrame: 12-month after index procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joo-Yong Hahn, MD, PhD
role: STUDY_CHAIR
References: