Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis

NCT03401203 | Completed DMC

• 1 other identifier: AMCCV2017-11
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief Summary

This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.

Conditions

Coronary Vessels

Keywords

ISR; ROTA; DEB; PCI

Outcome Measures

Primary Outcomes (1)

• In-segment minimal lumen diameter on angiographic

  1 year

Secondary Outcomes (7)

• Device success rate

  1 year

• Angiographic outcomes immediate after procedure

  1 hour

• OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area

  1 hour

• OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume

  1 hour

• Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis

  1 year

Study Arms (2)

rotational atherectomy followed by balloon angioplasty

EXPERIMENTAL

Procedure: Rotational atherectomy followed by balloon angioplasty

balloon angioplasty

ACTIVE COMPARATOR

Procedure: Balloon angioplasty

Interventions

Rotational atherectomy followed by balloon angioplasty PROCEDURE

Percutaneous coronary intervention

rotational atherectomy followed by balloon angioplasty

Balloon angioplasty PROCEDURE

Percutaneous coronary intervention

balloon angioplasty

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
• Subjects with coronary In-stent restenosis planned revascularization
• In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
• 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:

• Complex lesion anatomy that disables rotational atherectomy
• 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.
• Life expectancy \< 1 years for any non-cardiac or cardiac causes
• Unwillingness or inability to comply with the procedures described in this protocol.

Sponsors & Collaborators

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

Study Sites (3)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Angioplasty, Balloon

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

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, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 17, 2018
• Study Start: May 8, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

KR (3)