A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

LifeTech Scientific

Status

Unknown

Conditions

Single Coronary Vessel Disease

Treatments

Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03616132

IBS-FIM-MY

Details and patient eligibility

About

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.

Full description

A prospective, non-randomized trial
Study population: 15 patients
Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years;
All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years.
The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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:

Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months;
Patients who performed coronary artery bypass (coronary artery bypass grafting);
Patients with contraindications for coronary artery bypass graft surgery;
Severe heart failure (NYHA class III and above) or left ventricular ejection fraction<40% (ultrasonic or left ventricular angiography);
Preoperative renal function: serum creatinine > 2.0 mg/dl or 177 mu mol/L; receiving hemodialysis;
Patients have ischemic stroke half a year before implantation, patients have transient ischemic attack 3 months before implantation, patients have high coagulation tendency judged by investigator or laboratory examination;
Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy; patients would not allow to undergoing antithrombotic therapy;
Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer, rapamycin and metal allergies;
Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc;
The patient's life expectancy is less than 12 months;
Patient participated in other drug or medical device study and does not meet the primary study endpoint in clinical trials time frame;
Poor compliance and patients unable to complete the study in accordance with the requirements;
Patient with heart transplant;
The unstable arrhythmia, such as high risk ventricular extra systole and ventricular tachycardia;
Cancer needs chemotherapy;
Patients of immune suppression, autoimmune diseases, planned or undergoing immunosuppressive therapy;
Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc;
With six months for elective surgery requires stop using aspirin and clopidogrel;
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);
Patients with diffuse peripheral vascular disease; cannot use 6F catheter;
Patients with valvular surgery in the past.

Exclusion criteria by angiography:

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;
Severe calcified lesions and distorted disease which unable to predilation, lesion not suitable for stent delivery and expansion;
In-stent restenosis;
Myocardial bridge is involved in target lesion;
In order to reach the target lesion, study stent has to go through the previous implanted stent;
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.