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Quantitative Coronary Angiography Versus Imaging GUIDancE for Bioresorbable Vascular Scaffold Implantation (GUIDE-BVS)

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ClinicalTrials.gov Identifier: NCT02831218
Recruitment Status : Terminated (This study was merged into HOWTO-BRS study.)
First Posted : July 13, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
The purpose of this study is to compare clinical outcomes between QCA(quantitative coronary angiography)-guided and imaging-guided strategy in patients with native coronary artery disease undergoing Bioresorbable Vascular Scaffold implantation.

Condition or disease Intervention/treatment Phase
Percutaneous Transluminal Coronary Angioplasty Procedure: QCA and Aspirin Procedure: QCA and Clopidogrel Procedure: Imaging guided and Aspirin Procedure: Imaging guided and Clopidogrel Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: QCA and Aspirin alone Procedure: QCA and Aspirin
QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

Experimental: QCA and Clopidogrel alone Procedure: QCA and Clopidogrel
QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

Active Comparator: Imaging guided and Aspirin alone Procedure: Imaging guided and Aspirin
BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.

Active Comparator: Imaging guided and Clopidogrel alone Procedure: Imaging guided and Clopidogrel
BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.




Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 1 year ]
    the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.


Secondary Outcome Measures :
  1. Device success [ Time Frame: 1 day ]
    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA).

  2. Procedural success [ Time Frame: 24 hours ]
    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel myocardial infarction or repeat target lesion revascularization during the hospital stay (24 hour after an index procedure).

  3. Death [ Time Frame: 1 year and 5 years ]
  4. Myocardial infarction [ Time Frame: 1 year and 5 years ]
  5. Scaffold thrombosis [ Time Frame: 1 year and 5 years ]
  6. Stroke [ Time Frame: 1 year and 5 years ]
  7. Target lesion revascularization [ Time Frame: 1 year and 5 years ]
  8. Any revascularization [ Time Frame: 1 year and 5 years ]
  9. Target lesion failure [ Time Frame: 1 year and 5 years ]
    cardiac death, target vessel myocardial infarction or ischemia-driven target lesion failure

  10. event rate of net clinical events [ Time Frame: 5 years ]
    defined as composite event of cardiovascular death, myocardial infarction, stroke, clinically relevant bleeding



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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:

  • Men or women at least 18 years of age
  • Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention
  • Native coronary artery lesions with lesion length ≤ 50mm and reference vessel diameter of 2.3 - 3.75mm by QCA(quantitative coronary angiography) assessment
  • 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:

  • Angiographic exclusion criteria: any of the followings

    1. Small vessel: mean reference size < 2.3 mm by QCA(quantitative coronary angiography)
    2. True bifurcation lesion with a large side branch (reference vessel diameter > 2.3mm) requiring a complex two-stent approach
    3. Left main lesions
    4. Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending artery, or left circumflex artery
    5. Impaired delivery of the Absorb BVS is expected:
  • Extreme angulation (≥90°) proximal to or within the target lesion.
  • Excessive tortuosity (≥two 45° angles) proximal to or within the target lesion.
  • Moderate or heavy calcification proximal to or within the target lesion. 6. In-stent restenotic lesions
  • ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
  • Prior percutaneous coronary intervention within the target vessel during the last 12 months.
  • Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  • Left ventricular ejection fraction (LVEF) < 30%
  • Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
  • Persistent thrombocytopenia (platelet count <100,000/µl)
  • Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack (TIA) or ischemic stroke within the past 6 months
  • A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
  • Patients requiring long-term oral anticoagulants or cilostazol
  • Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
  • A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
  • Life expectancy < 5 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.
  • 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): NCT02831218


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Responsible Party: Seung-Jung Park, professor of medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02831218     History of Changes
Other Study ID Numbers: AMCCV2016-13
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by Seung-Jung Park, Asan Medical Center:
bioresorbable vascular scaffold
coronary artery disease

Additional relevant MeSH terms:
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors