Trials / Completed
CompletedNCT01186198
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 71 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
Conditions
- Ischemic Heart Disease
- Coronary Artery Stenosis
- Chronic Coronary Total Occlusion
- Coronary Bypass Graft Stenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MINI TREK RX 1.20 mm Coronary Dilatation Catheter | Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions |
Timeline
- Start date
- 2010-08-12
- Primary completion
- 2010-12-30
- Completion
- 2010-12-30
- First posted
- 2010-08-23
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01186198. Inclusion in this directory is not an endorsement.