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

Seung-Jung Park

Status: Terminated

Conditions: Percutaneous Transluminal Coronary Angioplasty

Treatments: Procedure: Imaging guided and Aspirin; Procedure: QCA and Aspirin; Procedure: Imaging guided and Clopidogrel; Procedure: QCA and Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02831218

AMCCV2016-13

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

70 participants in 4 patient groups

QCA and Aspirin alone

Experimental group

Treatment:

Procedure: QCA and Aspirin

QCA and Clopidogrel alone

Experimental group

Treatment:

Procedure: QCA and Clopidogrel

Imaging guided and Aspirin alone

Active Comparator group

Treatment:

Procedure: Imaging guided and Aspirin

Imaging guided and Clopidogrel alone

Active Comparator group

Treatment:

Procedure: Imaging guided and Clopidogrel