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

Seung-Jung Park95 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Vessels

Interventions

Rotational atherectomy followed by balloon angioplastyPROCEDURE

Percutaneous coronary intervention

Balloon angioplastyPROCEDURE

Percutaneous coronary intervention

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (3)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

In-segment minimal lumen diameter on angiographic

Time frame: 1 year

Secondary Outcomes

Device success rate

Time frame: 1 year

Angiographic outcomes immediate after procedure

In-segment and in-stent minimal lumen diameter and diameter stenosis

Time frame: 1 hour

OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area

Time frame: 1 hour

OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume

Time frame: 1 hour

Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis

Time frame: 1 year

OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss

Time frame: 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)

Data from ClinicalTrials.gov

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