Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis (ROTA-ISR)

Seung-Jung Park

Status

Completed

Conditions

Coronary Vessels

Treatments

Procedure: Balloon angioplasty

Procedure: Rotational atherectomy followed by balloon angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03401203

AMCCV2017-11

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.