Trial Search Results

A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medtronic Vascular

Stanford Investigator(s):

Intervention(s):

  • Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Age ≥ 75 years old

   - Any prior documented intracerebral bleed

   - Any documented stroke in the last 12 months

   - Hospital admission for bleeding during the prior 12 months

   - Renal failure defined as: Creatinine clearance <40 ml/min

   - Thrombocytopenia (PLT <100,000/mm3)

   - Severe chronic liver disease defined as: subjects who have developed any of the
   following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice

Exclusion Criteria:

   - Pregnant and breastfeeding women

   - Subjects requiring a planned PCI procedure after 1 month of index procedure

   - Active bleeding at the time of inclusion

   - Cardiogenic shock

   - A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin,
   P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its
   derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer
   coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless
   steel), zinc, or a sensitivity to contrast media, which cannot be adequately
   pre-medicated.

   - PCI during the previous 6 months for a lesion other than the target lesion of the
   index procedure

   - Participation in another clinical study within 12 months after index procedure

   - Subjects with life expectancy of less than 2 years

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting