Status:
ACTIVE_NOT_RECRUITING
The OCT SORT-OUT VIII Study
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Biosensors International
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital
Exclusion
- Age \<18 years
- Do not wish to participate
- Unable to provide written informed consent
- Domicile outside Denmark
- Do not speak Danish
- Inclusion in the SORT-OUT VIII study
- Inclusion in other stent studies
- Expected survival \<1 year
- Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
- Hypersensitivity to everolimus or biolimus
- The operator wishes to use other DES
- Reduced renal function; creatinine\> 120 mmol / L
- Only bare metal stent (BMS) implantation
- Only plain old balloon angioplasty (POBA)
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02253108
Start Date
May 1 2014
End Date
June 1 2026
Last Update
January 2 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
2
Odense University Hospital
Odense, Denmark, 5000