Debulking with Rotational atherectomy versus Balloon Angioplasty In Patients with In-stent Restenosis

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002913
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 April 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Men or women at least 19 years of age
Subjects with coronary ISR 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Angiography-measured in-segment minimal lumen area

Secondary Outcome Measures

Name	Time	Method
Device success rate;Angiographic outcomes immediate after procedure;OCT outcomes immediate after procedure : In-segment minimal lumen area loss;OCT outcomes immediate after procedure : In-stent minimal lumen area loss;OCT outcomes immediate after procedure : In-segment neointimal volume;OCT outcomes immediate after procedure : In-stent neointimal volume;Angiographic outcomes : In-segment late lumen loss;Angiographic outcomes : In-stent late lumen loss;Angiographic outcomes : In-segment minimal lumen diameter;Angiographic outcomes : In-stent minimal lumen diameter;Angiographic outcomes : In-segment diameter stenosis;Angiographic outcomes : In-stent diameter stenosis;OCT outcomes : in-segment late lumen area loss;OCT outcomes : in-stent late lumen area loss;composite event rate ; 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.