Symptomatic ischemic heart disease in de novo coronary artery lesions
Conditions
Interventions
Case series:N/A
Sponsors
Medtronic (Shanghai) Management Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged older than 18 years; 2. The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the IFU of the Endeavor Sprint; 3. The patient or legal representative has been informed of the nature of the PMS and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form; 4. Intention to implant at least one Endeavor Sprint during percutaneous coronary intervention (PCI); 5. The patient is willing and able to cooperate with protocol defined procedures and required follow up visits.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as Zotarolimus, rapamycin, tacrolimus, sirolimus or similar drugs, or any analogue or derivative, cobalt, chromium, nickel, molybdenum, or contrast media; 2. Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated; 3. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon; 4. Women with known pregnancy or who are lactating; 5. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons including life expectancy shorter than 5 years); 6. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current PMS requirements; 7. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period; 8. Previous enrollment in this Endeavor Sprint China PMS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device success;lesion success;Procedural success;-All deaths (cardiac and non-cardiac);Stent thrombosis rate;Myocardial infarction (Q wave and non-Q wave);Revascularization (TLR and TVR);Target vessel failure (TVF);Target lesion failure (TLF); | — |
Countries
China
Contacts
Public ContactKevin Lei
Medtronic (Shanghai) Management Co., Ltd.
Outcome results
None listed