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

NCT03401203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-01-04

No results posted yet for this study

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.

Conditions

  • Coronary Vessels

Interventions

PROCEDURE

Rotational atherectomy followed by balloon angioplasty

Percutaneous coronary intervention

PROCEDURE

Balloon angioplasty

Percutaneous coronary intervention

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER
  • Seung-Jung Park

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2022-12-01
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03401203 on ClinicalTrials.gov