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Trial record 24 of 77 for:    "Heart Disease" | "Cobalt"

Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease (ABSORB-LONG)

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ClinicalTrials.gov Identifier: NCT02831205
Recruitment Status : Terminated (Due to current BVS safety issue)
First Posted : July 13, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Duk-Woo Park, MD, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Percutaneous Transluminal Coronary Angioplasty Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold Device: everolimus-eluting cobalt-chromium (Xience) stent Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABSORB BVS Device: everolimus-eluting bioresorbable vascular (Absorb) scaffold
Other Name: ABSORB BVS

Active Comparator: XIENCE EES Device: everolimus-eluting cobalt-chromium (Xience) stent
Other Name: XIENCE EES




Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 1 year ]
    event rate for composite of cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-lesion revascularization


Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 5 years ]
  2. Target-vessel myocardial infarction [ Time Frame: 5 years ]
  3. Ischemia-driven target-lesion revascularization [ Time Frame: 5 years ]
  4. All-cause mortality [ Time Frame: 5 years ]
  5. event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction [ Time Frame: 5 years ]
  6. Any revascularization [ Time Frame: 5 years ]
    Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven

  7. Target-vessel failure [ Time Frame: 5 years ]
    death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization

  8. Stent thrombosis [ Time Frame: 5 years ]
  9. event rate of device success or procedural success [ Time Frame: 5 years ]

    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.


  10. Patient-reported angina status measured by Seattle angina questionnaire [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831205


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Duk-Woo Park, MD
CardioVascular Research Foundation, Korea

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Responsible Party: Duk-Woo Park, MD, professor of medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02831205     History of Changes
Other Study ID Numbers: AMCCV2016-14
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.
Keywords provided by Duk-Woo Park, MD, Asan Medical Center:
bioresorbable vascular scaffold
coronary artery disease
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chromium
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances