Atherosclerotic Coronary Disease
Conditions
Interventions
Case series:Nil
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Subject must be at least 18 years of age; 2. Subject must have evidence of myocardial ischemia,and suitable for percutaneous coronary intervention(PCI); 3. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery; 4. Subject, who is a woman of reproductive age (18-49 years old), must be confirmed non-pregnancy by her supervising physician before scaffold implantation; 5. Subject, who is a woman of reproductive age, must be not in her lactation period, and has no plan to suckle a baby for at least one year after the PCI procedure; 6. Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure; 7. Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XINSORB Scaffold and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure. Angiographic Inclusion Criteria: 1. Lesion(s) must be in a native coronary artery,and have a visually estimated diameter stenosis of >=50%; 2. Lesion(s) must be with Dmax by on-line quantitative coronary angiography (QCA) of >=2.75 mm and <=3.5 mm.
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Subject is at cardiogenic shock; 2. Subject's left ventricular ejection fraction (LVEF) is under 30% measured by transthoracic echocardiography or left ventricular angiography. To subjects with chronic coronary syndrome, the LVEF measurement was valid in 6 months. 3. Subject has high risk of bleeding, or history of bleeding tendency and clotting disorder, or major gastrointestinal bleeding within the past 6 months, or severe hematuria, or any contraindication to antiplatelet and anticoagulation; 4. Subject has known hypersensitivity to aspirin, heparin, clopidogrel, and other P2Y12 receptor inhibitor; 5. Subject has knwon allergy or contraindication to device materials and degradation product(Sirolimus, poly (L-lactide), poly (DL-lactide), lactide and lactate) that cannot be adequately pre-medicated; 6. Subject has allergy to contrast that cannot be adequately pre-medicated; 7. Elective surgery is planned within 365 days after the procedure that will require discontinuing either aspirin, or any P2Y12 receptor inhibitor; 8. Subject's target vessel is thought to require deferred PCI; 9. Subject's life expectancy is less than 5 years; 10. Subject is already participating in another clinical investigation that has not yet reached its primary endpoint. 11. Subject is unwilling to participate in the study; 12. Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures. Angiography Exclsion Criteria: 1. Target lesion in left main trunk; 2. Aorto-ostial target lesion (within 3 mm of the aorta junction); 3. Target lesion located within 3 mm of the origin of the LAD or LCX; 4. ''True'' medina bifurcation lesion (1,1,1) is required two-stent strategy; 5. Anatomical structure will hinder the XINSORB BRS to the proper position: 1) Excessive tortuosity (>=two 45 degree angles) proximal to or within the target lesion; 2) Extreme angulation (>=90 degree) proximal to or within the target lesion; 3) Heavy calcification proximal to or within the target lesion; 6. Target lesion involves myocardial bridge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Lumen Loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| the impact of ACR on physician decision-making;In Scaffold Minimal Lumen Area (MLA); | — |
Contacts
Public ContactLi Shen
Zhongshan Hospital, Fudan University
Outcome results
None listed