A First-in-Man Study of IBS

Not Applicable

Completed

• Conditions: Single Coronary Vessel Disease
• Interventions: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

• Registration Number: NCT03509142
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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

Study Timeline

• Study Start: 2018-04-10
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Primary Completion: 2019-07-19
• Study Completion: 2023-12-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBS implantation	Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System	Implantation of IBS in patients with coronary artery lesions. All the subjects will be assigned to cohort 1 (n=30) and cohort 2 (n=15).

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss	6 months after implantation	Late Lumen Loss
Study Device related Composite Endpoint (Target Lesion Failure)	6 months after implantation	Target Lesion Failure is defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).

Secondary Outcome Measures

Name	Time	Method
Analysis of percentage area obstruction by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Analysis of healing score by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Analysis of vessel area by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Analysis of scaffold area by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Analysis of percentage area obstruction by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Performance Evaluation of IBS	Immediate post procedure	4 class (Excellent, good, general, bad) to evaluate the push ability, performance of through the lesions, performance of cover the lesions, support force, withdraw ability.
Device related Composite Endpoint (DoCE)	1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure	Target Lesion Failure, defined as the composited endpoints of including cardiac death, target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR).
In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Angiographic Endpoint
In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Angiographic Endpoint
Analysis of incomplete strut apposition by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Analysis of lumen area by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Analysis of neointimal area by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Clinical Success	Hospitalized period post procedure within 7 days	Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.
Patient related Clinical Composite Endpoint (PoCE)	1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure	Including all-cause mortality, all myocardial infarction and any revascularization.
In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)	6 months, 1 year, 2 years, 3 years	Angiographic Endpoint
Analysis of neointimal thickness by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Analysis of proportion of strut coverage by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Analysis of volumetric obstruction by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Analysis of late recoil area by IVUS	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Intra-Vascular Ultrasound Endpoint
Thickness of acute stent recoil (mm)	Immediate post procedure	Angiographic Endpoint
In-stent, in-segment, proximal and distal late lumen loss (LLL)	1 year, 2 years, 3 years	Angiographic Endpoint
Vasomotion	6 months,1 year, 2 years, 3 years	Defined as the average diameter change of lumen diameter before and after using nitroglycerin.
Analysis of late recoil by OCT	Immediate post procedure, 6 months, 1 year, 2 years, 3 years	Optical Coherence Tomography Endpoint
Immediate Success Rate	Immediate post procedure	1. Device Success: Successfully transit and release the IBS at target lesion, then withdraw the delivery system. Immediate residual stenosis \< 30% and TIMI blood flow is class 3 (visual).; 2. Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion \< 30% and TIMI blood flow is class 3(visual).
Stent Thrombosis defined by ARC	Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year)	Timing (acute, sub-acute, late and very late) Evidence (definite and probable)

Trial Locations

Locations (1)

Beijing Fuwai hospital; 🇨🇳 Peking, China