Last reviewed · How we verify
COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-term Dual Anti-platelet Therapy: OCT (Optical Coherence Tomography) Evaluation in Comparison With DES
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual anti-platelet therapy (DAPT) for at least 6 months followed by aspirin. After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3). Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month follow up.
Details
| Lead sponsor | CeloNova BioSciences, Inc. |
|---|---|
| Phase | NA |
| Status | TERMINATED |
| Enrolment | 8 |
| Start date | 2014-06 |
| Completion | 2015-06 |
Conditions
- Stable Angina
Interventions
- Aspirin
- Resolute Integrity DES
- COBRA PzF
- DAPT
Primary outcomes
- Neointimal coverage of the stent as measured using OCT — 1 month
Neointimal coverage of the stent as measured using OCT - Neointimal coverage of the stent as measured using OCT — 3 months
Neointimal coverage of the stent as measured using OCT - Presence of thrombus formation as measured by OCT — 1 month
Presence of thrombus formation as measured by OCT - Presence of thrombus formation as measured by OCT — 3 months
Presence of thrombus formation as measured by OCT - Proportion of uncovered struts as measured by OCT — 1 month
Proportion of uncovered struts as measured by OCT - Proportion of uncovered struts as measured by OCT — 3 months
Proportion of uncovered struts as measured by OCT
Countries
Finland