NCT02224235

COBRA SHIELD OCT Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: CeloNova BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This study was terminated after enrollment of 8 patients due to insufficient enrollment

Conditions

• Stable Angina

Interventions

Type	Name	Description
DRUG	Aspirin	75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)
DEVICE	Resolute Integrity DES	Resolute Integrity DES
DEVICE	COBRA PzF
DRUG	DAPT	At the discretion of the investigator as to which DAPT is administered (per local practice)

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-08-25
• Last updated: 2020-10-06

Locations

2 sites across 1 country: Finland