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

Not Applicable

Completed

• Conditions: Coronary Vessels
• Interventions: Procedure: Balloon angioplasty; Procedure: Rotational atherectomy followed by balloon angioplasty

• Registration Number: NCT03401203
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-05-08
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-01
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balloon angioplasty	Balloon angioplasty	-
rotational atherectomy followed by balloon angioplasty	Rotational atherectomy followed by balloon angioplasty	-

Primary Outcome Measures

Name	Time	Method
In-segment minimal lumen diameter on angiographic	1 year

Secondary Outcome Measures

Name	Time	Method
Angiographic outcomes immediate after procedure	1 hour	In-segment and in-stent minimal lumen diameter and diameter stenosis
Device success rate	1 year
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
OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss	1 year
composite event rate	1 year	A composite event of following factors is defined as the occurrence of any event from these events and denoted that event as the union of these.; * Death (cardiac, vascular, non-cardiovascular); * Myocardial infarction (periprocedural, spontaneous); * Stent thrombosis (definite/probable); * Stroke; * Any revascularization; * Target lesion revascularization (TLR); * Target vessel revascularization (TVR); * Clinically significant bleeding (BARC type 2,3,4,5); * Target lesion failure (cardiac death, target vessel MI or ischemia-driven TLR); * Target vessel failure (cardiac death, target vessel MI or ischemia-driven TVR); * A composite of all-cause death, MI, any repeat revascularization; * A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding (Bleeding Academic Research Consortium (BARC) type 2,3,4,5)

Trial Locations

Locations (3)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of