Ischemic heart disease
Conditions
Interventions
MDT 2118 stent is placed in subjects who are acceptable candidates for treatment with a drug eluting stent in accordance with applicable guidelines for percutaneous coronary interventions, who additio
Sponsors
Medtronic Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects who are acceptable candidates for treatment with a DES in accordance with applicable guidelines for percutaneous coronary interventions, per manufacturer is Instructions for Use, who additionally meet pre-defined criteria for being high-bleeding risk and/or are candidates for 1-month DAPT and in the opinion of the investigator, the potential benefit of 1-month DAPT to the subject outweighs the potential risk. To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject must meet at least one of the following criteria: 1) Adjunctive chronic oral anticoagulation treatment planned to continue after PCI 2) Age >= 75 years old 3) Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure) 4) Any prior documented intracerebral bleed 5) Any documented stroke in the last 12 months 6) Hospital admission for major bleeding during the prior 12 months 7) Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment) 8) Planned daily NSAID (other than aspirin) or steroids for >= 30 days after PCI 9) Planned surgery that would require interruption of DAPT (within the next 12 months) 10) Renal failure defined as Creatinine clearance <40 ml/min 11) Thrombocytopenia (PLT <100,000/mm3) 12) Severe chronic liver disease defined as subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13) Expected non-compliance for at least 6 months DAPT for other medical reasons
Exclusion criteria
Exclusion criteria: 1) Pregnant and breastfeeding women 2) Subjects requiring a planned PCI procedure after one month of index procedure 3) Procedure planned to require non-study stents, stand-alone POBA, or stand-alone atherectomy 4) Active bleeding at the time of inclusion 5) Cardiogenic shock 6) Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure 7) Subject not expected to comply with long-term single antiplatelet therapy 8) A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g., 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. 9) PCI during the previous 6 months for a lesion other than the target lesion of the index procedure 10) Participation in another clinical study within 12 months after index procedure 11) Subjects with life expectancy of less than 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of cardiac death and myocardial infarction at one year for a one-month clear population [time frame: one month to one year] | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at all follow-up time points (1, 2, 6 months, 1 and 2 years), except acute success: Acute success (device, lesion, procedure) All deaths, including cardiac death Major adverse cardiac event (MACE) Defined as death, myocardial infarction, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods Composite of cardiac death and myocardial infarction Target vessel failure (TVF) Defined as cardiac death, target vessel myocardial infarction or clinically-driven target vessel revascularization Target vessel failure will be reported when ANY of the following events occur: Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel Cardiac death not clearly due to a non-target vessel endpoint Target vessel revascularization is determined Target lesion failure (TLF) Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods. All revascularizations (TLR, TVR and non-TVR) Stent thrombosis (def/prob) Stroke Bleeding per BARC criteria BARC 3 to 5 BARC 2 to 5 All BARC | — |
Countries
Japan,North America
Contacts
Public ContactAki Shiomitsu
Japan Clinical Research and Medical Science Clinical Research
Outcome results
None listed