Clinical trial NCT03509142: A First-in-Man Study of IBS
Official title: A Prospective, Single-Center, First-in-Man Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Coronary Vessel Disease
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 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 cohort 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in cohort 2.

The primary study endpoints:

1. Target lesion failure (TLF) at 6 months post procedure
2. Late Lumen Loss at 6 months post procedure

Eligibility criteria: 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 10\^9/L, or \> 700 x 10\^9/L, white blood cells \< 3 x 10\^9/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.

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Primary outcomes:
measure: Study Device related Composite Endpoint (Target Lesion Failure)
timeFrame: 6 months after implantation
measure: Late Lumen Loss
timeFrame: 6 months after implantation
Secondary outcomes:
measure: Immediate Success Rate
timeFrame: Immediate post procedure
measure: Clinical Success
timeFrame: Hospitalized period post procedure within 7 days
measure: Performance Evaluation of IBS
timeFrame: Immediate post procedure
measure: Device related Composite Endpoint (DoCE)
timeFrame: 1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
measure: Patient related Clinical Composite Endpoint (PoCE)
timeFrame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
measure: Stent Thrombosis defined by ARC
timeFrame: Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year)
measure: Thickness of acute stent recoil (mm)
timeFrame: Immediate post procedure
measure: In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: In-stent, in-segment, proximal and distal late lumen loss (LLL)
timeFrame: 1 year, 2 years, 3 years
measure: In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)
timeFrame: 6 months, 1 year, 2 years, 3 years
measure: Vasomotion
timeFrame: 6 months,1 year, 2 years, 3 years
measure: Analysis of neointimal thickness by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of proportion of strut coverage by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of incomplete strut apposition by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of percentage area obstruction by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of healing score by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of late recoil by OCT
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of vessel area by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of lumen area by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of scaffold area by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of neointimal area by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of percentage area obstruction by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of volumetric obstruction by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
measure: Analysis of late recoil area by IVUS
timeFrame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Peking
country: China
facility: Beijing Fuwai hospital
Study officials:
affiliation: Fu Wai Hospital, Beijing, China
name: Runlin Gao
role: STUDY_CHAIR
References: