Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

Official Title
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COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

Conditions
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Angina, Stable, Angina, Unstable, Anticoagulants

Intervention / Treatment
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* Device: COBRA PzF
* Device: Drug Eluting Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels). Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants. Written, informed consent Exclusion Criteria: Cardiogenic shock Target lesion located in left main trunk Bifurcation interventions with a planned 2-stent strategy Vessel size too small for implantation of a 2.5 mm stent by visual estimation Patient requiring staging PCI procedure within 6 months after the index procedure Patients requiring DAPT for more than 2 weeks after the index procedure Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months Relevant hematologic deviations: platelet count <100x10^9 cells/L or >600x10^9 cells/L Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives Patient's inability to fully cooperate with the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COBRA PzF<br>Cobra PzF plus 14-day DAPT (dual antiplatelet therapy) | Device: COBRA PzF<br> <br> |
| Active Comparator: Drug Eluting Stent<br>standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy) | Device: Drug Eluting Stent<br> <br> * Other names: Xience/Promus, Resolute or Synergy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is later). |  | 6 months | 
| Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke |  | 12 months | 
| Composite of cardiac death and myocardial infarction |  | 12 months | 
| Ischemia driven target lesion revascularization |  | 12 months | 
| Definite and probable stent thrombosis |  | 12 months | 
| Ischemic stroke |  | 12 months | 
| BARC class 3-5 bleeding |  | 6 months | 
| TIMI major bleeding; TIMI major and minor bleeding |  | 6 months | 
| Acute Success Rates | Device success; Lesion success; Procedure success | procedure | 
| Health economic utility | Total cardiovascular and bleeding related costs with cost effectiveness based on events avoided | 12 months |