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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616132
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Single Coronary Vessel Disease Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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)




Primary Outcome Measures :
  1. Study Device related Composite Endpoint (Target Lesion Failure) [ Time Frame: 1 month 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 :
  1. Immediate Success Rate [ Time Frame: Immediate postoperative ]
    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).

  2. Clinical Success [ Time Frame: Hospitalized period postoperative within 7 days ]
    Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.

  3. Performance Evaluation of IBS [ Time Frame: Immediate postoperative ]
    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.

  4. Device related Composite Endpoint (DoCE) [ Time Frame: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure ]
    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).

  5. Patient related Clinical Composite Endpoint (PoCE) [ Time Frame: 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure ]
    Including all-cause mortality, all myocardial infarction and target lesion revascularization.

  6. Stent Thrombosis defined by ARC [ Time Frame: 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)

  7. Acute stent retraction [ Time Frame: Immediate postoperative ]
    Angiographic Endpoint

  8. In-stent, in-segment, proximal and distal minimum lumen diameter (MLD) [ Time Frame: Immediate postoperative, 1 year, 3 years ]
    Angiographic Endpoint

  9. In-stent, in-segment, proximal and distal Diameter stenosis(DS) [ Time Frame: 1 year, 3 years ]
    Angiographic Endpoint

  10. In-stent, in-segment, proximal and distal Late lumen loss (LLL) [ Time Frame: 1 year, 3 years ]
    Angiographic Endpoint

  11. In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR) [ Time Frame: 1 year, 3 years ]
    Angiographic Endpoint

  12. Vasomotion [ Time Frame: 1 year, 3 years ]
    Defined as the average diameter change of lumen diameter before and after using nitroglycerin.

  13. Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT [ Time Frame: : Immediate postoperative, 1 year, 3 years ]
    Optical Coherence Tomography Endpoint

  14. Analysis of Vascular and scaffold morphology obtained with IVUS [ Time Frame: Immediate postoperative,1 year, 3 years ]
    Intra-Vascular Ultrasound Endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616132


Contacts
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Contact: Ying Xia +86 13760184511 xiaying@lifetechmed.com

Locations
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Malaysia
Institut Jantung Negara Not yet recruiting
Kuala Lumpur, Negeri Selangor, Malaysia
Principal Investigator: Jamauddin Bin Yahaya Shaiful Azmi         
University Malaya Medical Centre Recruiting
Kuala Lumpur, Negeri Selangor, Malaysia
Principal Investigator: Azman Wan Ahmad Wan         
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.

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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03616132    
Other Study ID Numbers: IBS-FIM-MY
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Iron
Sirolimus
Everolimus
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors