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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03401203

Acronym

ROTA-ISR

Enrollment

Registered

2018-01-17

Start date

2018-05-08

Completion date

2022-12-31

Last updated

2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Vessels

Keywords

ISR, ROTA, DEB, PCI

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.

Interventions

PROCEDURERotational atherectomy followed by balloon angioplasty

Percutaneous coronary intervention

PROCEDUREBalloon angioplasty

Percutaneous coronary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
In-segment minimal lumen diameter on angiographic	1 year

Secondary

Measure	Time frame	Description
Angiographic outcomes immediate after procedure	1 hour	In-segment and in-stent minimal lumen diameter and diameter stenosis
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	—
Device success rate	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)
Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis	1 year	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026