Trials / Completed
CompletedNCT01391871
Vascular Healing of DES at 3 Months
A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 3 Months After Deployment of PRO-Kinetic Drug-eluting Stent and Endeavor Resolute Zotarolimus-eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 46 (actual)
- Sponsor
- University of Turku · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
Detailed description
Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndrome. Design: A prospective, randomized and controlled study comparing coronary flow reserve and coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12 months. Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation. Secondary clinical endpoints: MACE and stent thrombosis. Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute DES).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCT | Optical coherence tomography |
| DEVICE | Transthoracic echocardiography CFR measurement | CFR will be assessed using transthoracic echocardiography with adenosine infusion. |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-07-01
- Completion
- 2013-07-01
- First posted
- 2011-07-12
- Last updated
- 2013-08-02
Locations
2 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT01391871. Inclusion in this directory is not an endorsement.