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

Coronary Vessels Clinical Trial

— ROTA-ISR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401203
• Other study ID #: AMCCV2017-11
• Status: Completed
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Vessels

Intervention

Procedure:
• Rotational atherectomy followed by balloon angioplasty
Percutaneous coronary intervention
• Balloon angioplasty
Percutaneous coronary intervention

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment minimal lumen diameter on angiographic		1 year
Secondary	Device success rate		1 year
Secondary	Angiographic outcomes immediate after procedure	In-segment and in-stent minimal lumen diameter and diameter stenosis	1 hour
Secondary	OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area		1 hour
Secondary	OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume		1 hour
Secondary	Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis		1 year
Secondary	OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss		1 year
Secondary	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