Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: A First-in-Man Study of IBS

Summary: The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System（IBS）. The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.

Detailed description: A prospective, single-center, First-in-Man trial;
  Study population: 45 subjects. The 45 subjects will be randomly assigned into two queues: queue 1(n=30), queue 2(n=15)
  The clinical follow up will be performed in all subjects at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years post procedure;
  The Angiographic, Intra-Vascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be performed at 6 months and 2 years post procedure in queue 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in queue 2.
  The primary study endpoint is target lesion failure (TLF) at 1 month post procedure, and imaging outcomes as the secondary study endpoint, to evaluate the feasibility, preliminary safety and efficacy of IBS.

Eligibility: Inclusion Criteria:
  All patients participating in this clinical trial must meet the following criteria:
  1. Age of 18-75， males or non pregnancy females;
  2. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
  3. One target lesion, and target lesion can be completely covered by a single stent;
  4. Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
  5. Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
  6. Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
  Exclusion Criteria:
  Patients will be excluded if any of the following conditions apply:
  General:
  1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
  2. Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
  3. Patients who had coronary artery bypass (coronary artery bypass grafting);
  4. Patients with contraindications for coronary artery bypass graft surgery;
  5. Severe heart failure (NYHA class III and above) or left ventricular ejection fraction<40% (ultrasonic or left ventricular angiography);
  6. Preoperative renal function: serum creatinine > 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
  7. Patients had ischemic stroke half a year before implantation, patients had transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination;
  8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
  9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
  10. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
  11. The patient's life expectancy is less than 12 months;
  12. Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
  13. Poor compliance and patients unable to complete the study in accordance with the requirements;
  14. Patient with heart transplant;
  15. The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
  16. Cancer needs chemotherapy;
  17. Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
  18. Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
  19. With six months for elective surgery requires stop using aspirin and clopidogrel;
  20. Blood test prompted platelet count < 100 x 109/L, or > 700 x 109/L, white blood cells < 3 x 109/L, or abnormal liver function (ALT、AST 3 times greater than normal range);
  21. Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
  22. Patients with valvular surgery in the past.
  Exclusion criteria by angiography:
  1. Chronic total occlusion (TIMI blood flow=0 before implantation) , left main coronary artery lesion, ostial lesion, multiple vessel lesion, branch lesion and bridge lesion which branch vessel diameter ≥ 2.0 mm (if the ostium of branch vessel stenosis >40% or needs balloon predilation); visible thrombus in target vessels;
  2. Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
  3. In-stent restenosis;
  4. Myocardial bridge is involved in target lesion;
  5. In order to reach the target lesion, study stent has to go through the previous implanted stent;
  6. Predilation balloon can't expand completely in target lesion site, judgment standard for fully expansion as below, patients are excluded when do not meet any item:
  A.DS% < 40%（visual），highly recommend DS% ≤20% B.TIMI blood flow= class 3（visual） C.No angiography complications (e.g., distal embolization, lateral branch closed) D.No interlining level NHLBI type D - F E.No continuous chest pain (> 5 minutes), and F.No lower or higher ST segment >5 minutes.
  -

Relevance to patient case: not relevant