Trials / Completed
CompletedNCT02504307
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation
Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Scitech Produtos Medicos SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sirolimus Eluting Stent Inspiron | Angioplasty with Sirolimus Eluting Stent Inspiron implantation |
| DEVICE | Bare Metal Stent | Angioplasty with Bare Metal Stent Cronus implantation |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2015-07-21
- Last updated
- 2018-08-14
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02504307. Inclusion in this directory is not an endorsement.