HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance

NCT ID: NCT03175523

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2022-07-07

Brief Summary

The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.

Detailed Description

The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.

Conditions

Coronary Stenosis

Study Design

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

Study Groups

Imaging guided Bioresorbable scaffold

Group Type: ACTIVE_COMPARATOR

imaging guided Bioresorbable scaffold implantation

Intervention Type: DEVICE

In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.

QCA-guided Bioresorbable scaffold

quantitative coronary angiography guided Bioresorbable scaffold

Group Type: EXPERIMENTAL

quantitative coronary angiography guided Bioresorbable scaffold implantation

Intervention Type: DEVICE

In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.

Interventions

quantitative coronary angiography guided Bioresorbable scaffold implantation

In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.

Intervention Type: DEVICE

imaging guided Bioresorbable scaffold implantation

In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men or women at least 19 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 less and reference vessel diameter of 2.5 ~ 3.75mm by 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 < 2.5 mm by 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, or left circumflex artery

5. Impaired delivery of the Absorb bio- resorbable vascular scaffold 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 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 Adenosine diphosphate(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 (alanine transaminase (ALT) or aspartate transaminase (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: 19 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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yang-soo Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMCCV2017-03

Identifier Type: -

Identifier Source: org_study_id