Trials / Active Not Recruiting
Active Not RecruitingNCT02253108
The OCT SORT-OUT VIII Study
Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Aarhus University Hospital Skejby · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.
Detailed description
Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Everolimus eluting bioresorbable polymer stent | |
| DEVICE | Biolimus eluting bioresorbable polymer stent |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-04-01
- Completion
- 2026-06-01
- First posted
- 2014-10-01
- Last updated
- 2026-01-02
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02253108. Inclusion in this directory is not an endorsement.