Quantitative Coronary Angiography Versus Imaging GUIDancE for Bioresorbable Vascular Scaffold Implantation

NCT ID: NCT02831218

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-09-30

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.

Conditions

Percutaneous Transluminal Coronary Angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QCA and Aspirin alone

Group Type: EXPERIMENTAL

QCA and Aspirin

Intervention Type: PROCEDURE

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.

QCA and Clopidogrel alone

Group Type: EXPERIMENTAL

QCA and Clopidogrel

Intervention Type: PROCEDURE

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.

Imaging guided and Aspirin alone

Group Type: ACTIVE_COMPARATOR

Imaging guided and Aspirin

Intervention Type: PROCEDURE

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.

Imaging guided and Clopidogrel alone

Group Type: ACTIVE_COMPARATOR

Imaging guided and Clopidogrel

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

Seung-Jung Park

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jung Park

professor of medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMCCV2016-13

Identifier Type: -

Identifier Source: org_study_id