A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
This study is a prospective, multi-center single arm registry trial, planning to enroll 785
 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2,
 3, 4, 5 year after index procedure. The primary endpoint will be target lesion failure (TLF)
 at 1 year after index procedure,which will be analyzed to evaluate the efficacy and safety of
 the device.
Inclusion Criteria:

 General Inclusion Criteria:

 1. Age from 18 to 75 years old, man or non-pregnant woman.

 2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old
 myocardial infarction, are suitable for selective PCI.

 3. Subjects without contraindications of coronary artery bypass grafting (CABG).

 4. Subjects are able to understand the purpose of this study, volunteer to participate
 and sign informed consent.

 Angiographic Inclusion Criteria:

 1. One or two de novo target lesions

 1. If subject has only one target lesion, the second non-target lesion must be
 treated but the non-target lesion must be present in a different epicardial
 vessel; the non target lesion must be treated first and successfully prior to the
 subjects' register.

 2. If there are two target lesions, they must be present in different epicardial
 vessels.

 3. The definition of epicardial vessels means the left anterior descending artery
 (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and
 their branches. Thus, for example, the subject must not have lesions requiring
 treatment in both the LAD and a branch.

 2. Target lesion diameter stenosis is estimated visually ≥ 70% (or ≥ 50% with clinical
 evidence of myocardial ischemia), with TIMI flow grade ≥1; Target lesion length ≤24mm
 (visually); target lesion diameter between ≥2.5 mm to ≤ 4.00 mm.

 3. Each target lesion must be covered completely by one scaffold.

 Exclusion Criteria:

 General Exclusion Criteria:

 1. Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does
 not return to normal level after myocardial infarction.

 2. Target vessel has been implanted with stents within 1 year before procedure.

 3. Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection
 fraction <35% (accessed by ultrasound or left ventricular angiography).

 4. subject with severe kidney functional damaged before procedure: serum creatinine>2.0mg
 /dl (176.8μmol / L) or subject is receiving hemodialysis.

 5. Subjects with high bleeding risk, with active gastrointestinal ulcers, history of
 cerebral hemorrhage or history of subarachnoid hemorrhage, history of ischemic stroke
 within the past six months, with contraindications of anti-platelet agents and
 anticoagulants, and subjects cannot receive antithrombolytic therapy.

 6. subject is known hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast
 agent, polylactic acid polymer and rapamycin.

 7. The subject's life expectancy is less than 24 months.

 8. Subjects is currently participating in other drug or medical device clinical trial
 that has not yet completed its primary endpoint .

 9. Subjects have received any solid organ transplants or are ready to undergo organ
 transplant.

 10. Subjects have unstable arrhythmia, such as high-risk ventricular premature beats, and
 ventricular tachycardia.

 11. Subjects receive chemotherapy for tumor.

 12. Subjects have received or planning to receive coronary or chest radiotherapy.

 13. Subjects with Immunosuppressive, autoimmune diseases, have planned to receive or
 underwent immunosuppressive therapy.

 14. Subjects have planned to receive or are receiving long-term anticoagulation therapy,
 such as heparin, warfarin and so on.

 15. Subjects have planned to receive selective surgery within 6 months, which requires
 them to discontinue aspirin or clopidogrel.

 16. Blood tests showed that the platelet count is less than 100 × 10^9 / L, or more than
 700 × 10^9 / L, the white blood cells count is less than 3 × 10^9 /L.

 17. subject with diagnosed or suspected liver cirrhosis.

 18. Subjects with diffuse peripheral vascular disease, that precludes safe 6 French sheath
 insertion.

 Angiographic exclusion criteria:

 These exclusion criteria apply to the target or non-target lesion(s), target or non-target
 vessel(s):

 1. Target or non-target lesion(s) located in left main.

 2. Subjects with triple vessel lesion in LAD, LCX or RCA, which all need to be treated.

 These exclusion criteria apply to the target lesion(s) or target vessel(s):

 1. Target lesion located in left main.

 2. Target lesion located in the aorto-ostial of RCA (within 3 mm of the origin of the
 RCA).

 3. Target lesion located within 3 mm of the origin of the LAD and LCX.

 4. Lesion involving a bifurcation with a:

 1. Side branch ≥ 2.5 mm in diameter, or

 2. Side branch with diameter stenosis ≥ 50%, or

 3. Side branch requiring protection guide wire, or

 4. Side branch requiring pre-dilatation.

 5. Anatomy proximal to or within the lesion that may affect delivery of the Bioheart,
 including:

 1. Extreme angulation (≥ 90°) proximal to or within the target lesion, or

 2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion,
 or

 3. Moderate or heavy calcification proximal to or within the target lesion.

 6. Target lesion involves a myocardial bridge.

 7. Target vessel contains thrombus as indicated in the angiographic images or IVUS.

 8. Prior to the index procedure target vessel has been previously treated with a stent at
 any time such that the Bioheart stent would need to cross the stent to reach the
 target lesion.

 9. Target vessel has been previously treated with a stent and the target lesion is within
 5 mm proximal to a previously treated lesion.

 10. Target lesion cannot meet the following outcomes, after the complete balloon
 pre-dilatation:

 1. Residual (DS %) is < 40% (per visual estimation), ≤ 20% is strongly recommended;

 2. TIMI Grade-3 flow (per visual estimation);

 3. No angiographic complications (e.g., no-reflow, distal embolization, side branch
 closure)

 4. No dissections NHLBI grade D-F;

 5. No chest pain lasting > 5 minutes, and;

 6. No ST depression or elevation lasting > 5 minutes.