HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance (HOWTO-BRS)

Seung-Jung Park

Status

Terminated

Conditions

Coronary Stenosis

Treatments

Device: imaging guided Bioresorbable scaffold implantation

Device: quantitative coronary angiography guided Bioresorbable scaffold implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT03175523

AMCCV2017-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Angiographic exclusion criteria: any of the followings
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.