AzTrials
AzTrials

Coronary Artery DiseaseSMART-BRS-ISRNCT03074305

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

A study testing PCI for in-bioresorbable scaffold stenosis in people with Coronary Artery Disease and Coronary Restenosis, run by Samsung Medical Center at 1 site in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Coronary Artery Disease, Coronary Restenosis
What is being tested?
PCI for in-bioresorbable scaffold stenosis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSouth Korea
Study dates
8 Mar 2017to 25 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
PCI for in-bioresorbable scaffold stenosis
Keywords
In-bioresorbable vascular scaffold restenosis, drug-eluting stent, drug-eluting balloon, bioresorbable scaffold
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI for in-bioresorbable scaffold stenosisDevice

    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
Study groups in NCT03074305
Study groupRoleWhat they receive
DEB strategyActive comparatorDEB 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
Receives: Device: PCI for in-bioresorbable scaffold stenosis
DES strategyActive comparatorThe 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.
Receives: Device: PCI for in-bioresorbable scaffold stenosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI

    Measured: 13-month after index procedure

Secondary outcomes (14)

  1. post-PCI FFR value

    Measured: Immediate after index procedure

  2. post-PCI MLD

    Measured: Immediate after index procedure

  3. minimum stent area (MSA) measured by intravascular ultrasound (IVUS)

    Measured: Immediate after index procedure

  4. minimum stent area measured by optical coherence tomography (OCT)

    Measured: Immediate after index procedure

  5. follow-up FFR

    Measured: 13-month after index procedure

  6. 13-month follow-up minimal stent area measured by IVUS or OCT

    stratified analysis according to imaging modality

    Measured: 13-month after index procedure

  7. OCT findings in neoatherosclerotic tissue

    macrophage infiltration, presence of thin-cap fibrous neoatheroma (TCNA), patterns of neoatherosclerotic tissue (homogeneous, heterogeneous, layered, neoatherosclrotic), cap thickness

    Measured: 13-month after index procedure

  8. All-cause mortality

    Measured: 12-month after index procedure

  9. Cardiac death

    Measured: 12-month after index procedure

  10. Any myocardial infarction

    Measured: 12-month after index procedure

  11. 12-month follow up any revascularization

    Measured: 12-month after index procedure

  12. Target vessel revascularization

    Measured: 12-month after index procedure

  13. Stent thrombosis

    Measured: 12-month after index procedure

  14. Major adverse cardiovascular events

    a composite of cardiac death, target-vessel MI, and target lesion revascularization

    Measured: 12-month after index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study start8 Mar 2017
  3. Primary completion30 Dec 2017
  4. Study completion25 Jan 2018

Why it stopped: cannot use bioabsorbable scaffold

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, open label, two-arm, randomized controlled trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03074305
Sponsor's protocol ID
BRS-ISR16453143
Acronym
SMART-BRS-ISR
Status last verified
Apr 2024
First submitted
4 Mar 2017
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Questions about this trial

What is this clinical trial studying?

A study testing PCI for in-bioresorbable scaffold stenosis in people with Coronary Artery Disease and Coronary Restenosis, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI (time frame: 13-month after index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03074305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in