Status:
COMPLETED
Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Vessels
Eligibility:
All Genders
19+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03401203
Start Date
May 8 2018
End Date
December 31 2022
Last Update
January 4 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
2
Chonnam National University Hospital
Gwangju, South Korea
3
Asan Medical Center
Seoul, South Korea