Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE)

CeloNova BioSciences

Status: Unknown

Conditions: Angina, Stable; Anticoagulants; Angina, Unstable

Treatments: Device: COBRA PzF; Device: Drug Eluting Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02594501

COBRA 2015-01

Details and patient eligibility

About

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.

Enrollment: 996 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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996 participants in 2 patient groups

COBRA PzF

Experimental group

Description:

Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)

Treatment:

Device: COBRA PzF

Drug Eluting Stent

Active Comparator group

Description:

standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)

Treatment:

Device: Drug Eluting Stent