Trials / Completed
CompletedNCT00485004
Focal In-stent Restenosis After Drug-Eluting Stent
FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Seung-Jung Park · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Detailed description
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cutting balloon | Cutting balloon |
| DEVICE | Sirolimus-eluting stent | Sirolimus-eluting stent |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2007-06-12
- Last updated
- 2012-08-08
Locations
15 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00485004. Inclusion in this directory is not an endorsement.