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

Coronary Stenosis Clinical Trial

— HOWTO-BRS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03175523
• Other study ID #: AMCCV2017-03
• Status: Terminated
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: July 7, 2022
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.	1 year
Secondary	Device success	Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA).	1 hour after an index procedure
Secondary	Procedural success	Achievement of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel myocardial infarction or repeat target lesion revascularization during the hospital stay.	24 hours after an index procedure
Secondary	Death	cardiac, vascular, non-cardiovascular	1 year, and 5 years
Secondary	Myocardial infarction		1 year, and 5 years
Secondary	Scaffold thrombosis		1 year, and 5 years
Secondary	Stroke		1 year, and 5 years
Secondary	Target lesion revascularization		1 year, and 5 years
Secondary	Any revascularization		1 year, and 5 years
Secondary	Target lesion failure (TLR)	cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization	1 year, and 5 years
Secondary	A composite event	a composite event of cardiac death, target vessel myocardial infarction, stroke, or clinically significant bleeding(clinically significant bleeding by Bleeding Academic Research Consortium (BARC) type 2,3,4,5)	1 year, and 5 years
Secondary	In-scaffold restenosis on coronary CT angiography		1 year, and 5 years