COBRA SHIELD OCT Study

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02224235
Study type	Interventional
Source	CeloNova BioSciences, Inc.
Contact
Status	Terminated
Phase	N/A
Start date	June 2014
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02892903` - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?	N/A
Not yet recruiting	`NCT02871622` - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM	N/A
Not yet recruiting	`NCT02550301` - Does Mean Platelet Volume Change With Clopidogrel	N/A
Completed	`NCT02252406` - Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome	Phase 4
Active, not recruiting	`NCT02244853` - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease	N/A
Completed	`NCT01826552` - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent	Phase 4
Not yet recruiting	`NCT01162902` - Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation	Phase 4
Completed	`NCT02126150` - United Coronary Biobanks	N/A
Completed	`NCT01328470` - Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease	Phase 4
Completed	`NCT01769079` - Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina	Phase 4
Unknown status	`NCT00751491` - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI)	Phase 3
Completed	`NCT00263263` - RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.	Phase 2
Active, not recruiting	`NCT04929496` - Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study	N/A
Completed	`NCT03103620` - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Recruiting	`NCT05459051` - Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina
Completed	`NCT06464276` - Effectiveness and Tolerability of Trimetazidine 80mg Once Daily in Patients With Chronic Coronary Syndrome: The V-GOOD Study
Not yet recruiting	`NCT04403048` - Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID	N/A
Completed	`NCT01974492` - Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting	N/A
Completed	`NCT01990924` - Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention	N/A
Completed	`NCT02120859` - Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty	Phase 4