Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Vascular
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
Any prior documented intracerebral bleed
Any documented stroke in the last 12 months
Hospital admission for bleeding during the prior 12 months
Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
Planned surgery that would require interruption of DAPT (within the next 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
Expected non-compliance for at least 6 months DAPT for other medical reasons
You may not be if
Pregnant and breastfeeding women
Subjects requiring a planned PCI procedure after 1 month of index procedure
Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
Active bleeding at the time of inclusion
Cardiogenic shock
Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
Subject not expected to comply with long-term single antiplatelet therapy
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
