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

A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

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.

Study Overview

• Status: Recruiting
• Conditions: Single Coronary Vessel Disease
• Intervention / Treatment: Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Negeri Selangor
    • Kuala Lumpur, Negeri Selangor, Malaysia
      • Not yet recruiting
      • Institut Jantung Negara
      • Principal Investigator: Jamauddin Bin Yahaya Shaiful Azmi
    • Kuala Lumpur, Negeri Selangor, Malaysia
      • Recruiting
      • University Malaya Medical Centre
      • Principal Investigator: Azman Wan Ahmad Wan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 performed 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 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;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IBS implantation; Implantation of IBS in patients with coronary artery lesions.	Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System; Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Device related Composite Endpoint (Target Lesion Failure)	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).	1 month after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Success Rate	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).; Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion < 30% and TIMI blood flow is class 3(visual).	Immediate postoperative
Clinical Success	Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.	Hospitalized period postoperative within 7 days
Performance Evaluation of IBS	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.	Immediate postoperative
Device related Composite Endpoint (DoCE)	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), also known as MACE (major adverse cardiac events).	6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure
Patient related Clinical Composite Endpoint (PoCE)	Including all-cause mortality, all myocardial infarction and target lesion revascularization.	30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure
Stent Thrombosis defined by ARC	Timing (acute, sub-acute, late and very late) Evidence (definite and probable)	Acute(0-24 hours), Subacute(24 hours-30 days), Late(30 days-1 year),Very late(after 1 year)
Acute stent retraction	Angiographic Endpoint	Immediate postoperative
In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)	Angiographic Endpoint	Immediate postoperative, 1 year, 3 years
In-stent, in-segment, proximal and distal Diameter stenosis(DS)	Angiographic Endpoint	1 year, 3 years
In-stent, in-segment, proximal and distal Late lumen loss (LLL)	Angiographic Endpoint	1 year, 3 years
In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)	Angiographic Endpoint	1 year, 3 years
Vasomotion	Defined as the average diameter change of lumen diameter before and after using nitroglycerin.	1 year, 3 years
Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT	Optical Coherence Tomography Endpoint	: Immediate postoperative, 1 year, 3 years
Analysis of Vascular and scaffold morphology obtained with IVUS	Intra-Vascular Ultrasound Endpoint	Immediate postoperative,1 year, 3 years

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2018
• Primary Completion (ANTICIPATED): March 30, 2019
• Study Completion (ANTICIPATED): March 30, 2023

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: IBS-FIM-MY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No