NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: NeoVas BCS
Intervention description: The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: NeoVas; Bioresorbable scaffold; Sirolimus; First-in-Man

Summary:

      The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will
      enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical
      feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold
      in the treatment of patients with de novo coronary lesion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age must be between 18 and 75 years, men or unpregnant women

          -  Patient must have evidence of myocardial ischemia (e.g., stable angina, unstable
             angina)

          -  Total number of target lesion =1 per patient

          -  Target lesion must be ≤ 20mm in length (visual estimation) and 2.75 to 3.75 mm in
             diameter（Online QCA）

          -  Target lesion is with a visually estimated stenosis of ≥ 70% (or ≥50% and evidence of
             myocardial ischemia) with a TIMI flow of ≥ 1

          -  The target lesion can be covered by one scaffold

          -  Patient must be an acceptable candidate for coronary artery bypass graft.

          -  Patient is able to verbally confirm understanding of risks, benefits and treatment of
             receiving the NeoVas bioresorbable coronary scaffold and he/she or his/her legally
             authorized representative provides written informed consent prior to any clinical
             investigation related procedure, as approved by the appropriate Ethics Committee of
             the respective clinical site.

        Exclusion Criteria:

          -  Patients has had a known diagnosis of acute myocardial infarction (AMI) within 30 days
             preceding the procedure; CK and CK-MB have not returned within normal limits at the
             time of procedure

          -  Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left
             trunk vessel lesion, ostial lesion ,multi-branch lesions needing treated, fork and
             bridge vessel lesions of branch vessels whose diameter ≥2.0mm(branch opening stenosis
             exceeds 40% or need balloon expansion); there is thrombus visible in the target blood
             vessels.

          -  Severe calcified lesions and twisted lesions which cannot be pre-expanded, and lesions
             unsuitable for delivering and expanding stents

          -  In-stent restenosis lesion

          -  Patient has undergone previous stenting anywhere within the target vessel(s) within
             the previous 12 months, or will require stenting within the target vessel(s) within 6
             months after the study procedure; target vessels that has been planted stents over a
             year.

          -  Severe heart failure(over NYHA III grade ), or left ventricular ejection
             fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography )

          -  Known renal insufficiency (e.g., eGFR <60 ml/min, or subject on dialysis)

          -  Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral
             hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a
             year, and these patients who contraindicate against platelet inhibitors and
             anticoagulant therefore can not bear anticoagulation treatment

          -  Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel,
             heparin, contrast agent, polylactic acid or sirolimus that cannot be adequately
             pre-medicated

          -  Life expectancy < 12 months

          -  Patient is participating in another device or drug study that has not reached the
             primary endpoint of the study.

          -  Patient's inability to fully cooperate with the study protocol which in the
             investigator's opinion may limit his/her ability to participate in the study

          -  Patient has a heart transplant.

          -  Patient has current unstable arrhythmias, such as high risk ventricular premature beat
             and ventricular tachycardia.

          -  Patient is receiving or scheduled to receive chemotherapy for malignancy within 30
             days prior to or after the procedure

          -  Patient is receiving immunosuppression therapy and has known immunosuppressive or
             autoimmune disease

          -  Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g.,
             heparin, coumadin)

          -  Elective surgery is planned within the first 6 months after the procedure that will
             require discontinuing either aspirin or clopidogrel

          -  Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or
             documented or suspected liver disease (including laboratory evidence of hepatitis)

          -  Patient has extensive peripheral vascular disease that precludes safe 6 French sheath
             insertion