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

A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial

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.

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.