Clinical trial NCT03175523: HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance
Official title: HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Stenosis
Keywords: BioResorbable Scaffold
Quantitative Coronary Angiography
Intravascular Imaging
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2017-06-05
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* 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.

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Device success
timeFrame: 1 hour after an index procedure
measure: Procedural success
timeFrame: 24 hours after an index procedure
measure: Death
timeFrame: 1 year, and 5 years
measure: Myocardial infarction
timeFrame: 1 year, and 5 years
measure: Scaffold thrombosis
timeFrame: 1 year, and 5 years
measure: Stroke
timeFrame: 1 year, and 5 years
measure: Target lesion revascularization
timeFrame: 1 year, and 5 years
measure: Any revascularization
timeFrame: 1 year, and 5 years
measure: Target lesion failure (TLR)
timeFrame: 1 year, and 5 years
measure: A composite event
timeFrame: 1 year, and 5 years
measure: In-scaffold restenosis on coronary CT angiography
timeFrame: 1 year, and 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Yonsei University
name: Yang-soo Jang, MD
role: PRINCIPAL_INVESTIGATOR
References: