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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Vessels

Intervention / Treatment
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* Procedure: Rotational atherectomy followed by balloon angioplasty
* Procedure: Balloon angioplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rotational atherectomy followed by balloon angioplasty<br> | Procedure: Rotational atherectomy followed by balloon angioplasty<br>* Percutaneous coronary intervention<br>|
| Active Comparator: balloon angioplasty<br> | Procedure: Balloon angioplasty<br>* Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment minimal lumen diameter on angiographic |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate |  | 1 year | 
| Angiographic outcomes immediate after procedure | In-segment and in-stent minimal lumen diameter and diameter stenosis | 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 | 
| OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss |  | 1 year | 
| 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. 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) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ISR, ROTA, DEB, PCI