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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Vessels
• Intervention / Treatment: Procedure: Rotational atherectomy followed by balloon angioplasty; Procedure: Balloon angioplasty

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rotational atherectomy followed by balloon angioplasty	Procedure: Rotational atherectomy followed by balloon angioplasty; Percutaneous coronary intervention
Active Comparator: balloon angioplasty	Procedure: Balloon angioplasty; Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 25, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: PCI; DEB; ISR; ROTA
• Other Study ID Numbers: AMCCV2017-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No