Trials / Completed
CompletedNCT03401203
Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Seung-Jung Park · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Rotational atherectomy followed by balloon angioplasty | Percutaneous coronary intervention |
| PROCEDURE | Balloon angioplasty | Percutaneous coronary intervention |
Timeline
- Start date
- 2018-05-08
- Primary completion
- 2022-12-01
- Completion
- 2022-12-31
- First posted
- 2018-01-17
- Last updated
- 2023-01-04
Locations
3 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03401203. Inclusion in this directory is not an endorsement.