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

NCT03175523 | Terminated DMC

• 1 other identifier: AMCCV2017-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis

Keywords

BioResorbable Scaffold; Quantitative Coronary Angiography; Intravascular Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Device success

  1 hour after an index procedure

• Procedural success

  24 hours after an index procedure

• Death

  1 year, and 5 years

• Myocardial infarction

  1 year, and 5 years

• Scaffold thrombosis

  1 year, and 5 years

Study Arms (2)

Imaging guided Bioresorbable scaffold

ACTIVE COMPARATOR

Device: imaging guided Bioresorbable scaffold implantation

QCA-guided Bioresorbable scaffold

EXPERIMENTAL

quantitative coronary angiography guided Bioresorbable scaffold

Device: quantitative coronary angiography guided Bioresorbable scaffold implantation

Interventions

quantitative coronary angiography guided Bioresorbable scaffold implantation 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.

QCA-guided Bioresorbable scaffold

imaging guided Bioresorbable scaffold implantation 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.

Imaging guided Bioresorbable scaffold

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Small vessel: mean reference size \< 2.5 mm by quantitative coronary angiography
• True bifurcation lesion with a large side branch (reference vessel diameter \> 2.3mm) requiring a complex two-stent approach
• Left main lesions
• Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending, or left circumflex artery
• 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.
• 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)

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yang-soo Jang, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: September 29, 2017
• Primary Completion: February 20, 2019
• Study Completion: July 7, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

KR (1)