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Percutaneous Transluminal Coronary AngioplastyPhase 4ABSORB-LONGNCT02831205

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease

A Phase 4 study testing everolimus-eluting bioresorbable vascular (Absorb) scaffold and everolimus-eluting cobalt-chromium (Xience) stent in people with Percutaneous Transluminal Coronary Angioplasty, run by Duk-Woo Park, MD at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
everolimus-eluting bioresorbable vascular (Absorb) scaffold and everolimus-eluting cobalt-chromium (Xience) stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
1 siteSouth Korea
Study dates
Jul 2016to Dec 2017
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 and more
  • Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
  • Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Who cannot join

  • Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
  • Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
  • An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
  • STEMI requiring primary percutaneous coronary intervention
  • Cardiogenic shock
  • Restenotic lesions
Show all 14Show fewer
  • Left main
  • Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
  • Heavy calcification proximal to or within the target lesion
  • Compromised left ventricular dysfunction (LVEF <30%)
  • At the time of screening, the subject has a malignancy that is not in remission
  • Terminal illness with life expectancy <1 year
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • Patient's pregnant or breast-feeding or child-bearing potential

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.

Being tested
everolimus-eluting bioresorbable vascular (Absorb) scaffold, everolimus-eluting cobalt-chromium (Xience) stent
Keywords
bioresorbable vascular scaffold, coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • everolimus-eluting bioresorbable vascular (Absorb) scaffoldDevice

    Also called ABSORB BVS

  • everolimus-eluting cobalt-chromium (Xience) stentDevice

    Also called XIENCE EES

Study groups in NCT02831205
Study groupRoleWhat they receive
ABSORB BVSExperimentalNot described
Receives: Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold
XIENCE EESActive comparatorNot described
Receives: Device: everolimus-eluting cobalt-chromium (Xience) stent

What is being measured

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

  1. Target lesion failure

    event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization

    Measured: 1 year

Secondary outcomes (10)

  1. Cardiac death

    Measured: 5 years

  2. Target-vessel myocardial infarction

    Measured: 5 years

  3. Ischemia-driven target-lesion revascularization

    Measured: 5 years

  4. All-cause mortality

    Measured: 5 years

  5. event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction

    Measured: 5 years

  6. Any revascularization

    Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven

    Measured: 5 years

  7. Target-vessel failure

    death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization

    Measured: 5 years

  8. Stent thrombosis

    Measured: 5 years

  9. event rate of device success or procedural success

    Device success defined as angiographic evidence of <30% final residual stenosis of the target lesion.

    Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.

    Measured: 5 years

  10. Patient-reported angina status measured by Seattle angina questionnaire

    Measured: 5 years

Timeline

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

  1. First posted13 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: Due to current BVS safety issue

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831205
Sponsor's protocol ID
AMCCV2016-14
Acronym
ABSORB-LONG
Status last verified
Dec 2017
First submitted
6 Jul 2016
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: This is not a publicly funded trial.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing everolimus-eluting bioresorbable vascular (Absorb) scaffold and everolimus-eluting cobalt-chromium (Xience) stent in people with Percutaneous Transluminal Coronary Angioplasty, run by Duk-Woo Park, MD 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 15 Dec 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to current BVS safety issue). Results are not available in the source record.

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?

Target lesion failure (time frame: 1 year). 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 NCT02831205.

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 15 Dec 2017.

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