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

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.

Study Overview

• Status: Terminated
• Conditions: Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Procedure: QCA and Aspirin; Procedure: QCA and Clopidogrel; Procedure: Imaging guided and Aspirin; Procedure: Imaging guided and Clopidogrel

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	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).	1 day
Procedural success	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).	24 hours
Death		1 year and 5 years
Myocardial infarction		1 year and 5 years
Scaffold thrombosis		1 year and 5 years
Stroke		1 year and 5 years
Target lesion revascularization		1 year and 5 years
Any revascularization		1 year and 5 years
Target lesion failure	cardiac death, target vessel myocardial infarction or ischemia-driven target lesion failure	1 year and 5 years
event rate of net clinical events	defined as composite event of cardiovascular death, myocardial infarction, stroke, clinically relevant bleeding	5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 10, 2016
• First Posted (ESTIMATE): July 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; bioresorbable vascular scaffold
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: AMCCV2016-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.