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Single Coronary Vessel DiseaseNCT03616132

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

A study testing Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System in people with Single Coronary Vessel Disease, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 2 sites in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Single Coronary Vessel Disease
What is being tested?
Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesMalaysia
Study dates
28 Mar 2018to 30 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients participating in this clinical trial must meet the following criteria:
  • Age of 18-75， males or non pregnancy females;
  • Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI;
  • One target lesion, and target lesion can be completely covered by a single stent;
  • Target lesion length ≤ 18 mm, target lesion diameter between 3.0 mm to 3.5 mm (visual);
  • Visual assessment of target lesion stenosis ≥70%, TIMI blood flow≥ 1;
  • Subject who understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Who cannot join

  • 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;
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  • 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.
  • 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:
  • 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.

Trial locations and contacts

2 sites in 1 country.

Ying Xia contact

+86 13760184511

xiaying@lifetechmed.com

Malaysia2 sites, 2 recruiting

  • Institut Jantung Negara

    Kuala Lumpur, Negeri Selangor

    Jamauddin Bin Yahaya Shaiful Azmi

    Not yet recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Negeri Selangor

    Azman Wan Ahmad Wan

    Recruiting

Other trials in Malaysia

About this study

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

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.

Read the 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.
Being tested
Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold SystemDevice

    Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)

Study groups in NCT03616132
Study groupRoleWhat they receive
IBS implantationExperimentalImplantation of IBS in patients with coronary artery lesions.
Receives: Device: Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 month after implantation

Secondary outcomes (14)

  1. Immediate Success Rate

    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).

    Measured: Immediate postoperative

  2. Clinical Success

    Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.

    Measured: Hospitalized period postoperative within 7 days

  3. 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.

    Measured: Immediate postoperative

  4. 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).

    Measured: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure

  5. Patient related Clinical Composite Endpoint (PoCE)

    Including all-cause mortality, all myocardial infarction and target lesion revascularization.

    Measured: 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure

  6. Stent Thrombosis defined by ARC

    Timing (acute, sub-acute, late and very late) Evidence (definite and probable)

    Measured: Acute(0-24 hours), Subacute(24 hours-30 days), Late(30 days-1 year),Very late(after 1 year)

  7. Acute stent retraction

    Angiographic Endpoint

    Measured: Immediate postoperative

  8. In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)

    Angiographic Endpoint

    Measured: Immediate postoperative, 1 year, 3 years

  9. In-stent, in-segment, proximal and distal Diameter stenosis(DS)

    Angiographic Endpoint

    Measured: 1 year, 3 years

  10. In-stent, in-segment, proximal and distal Late lumen loss (LLL)

    Angiographic Endpoint

    Measured: 1 year, 3 years

  11. In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)

    Angiographic Endpoint

    Measured: 1 year, 3 years

  12. Vasomotion

    Defined as the average diameter change of lumen diameter before and after using nitroglycerin.

    Measured: 1 year, 3 years

  13. Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT

    Optical Coherence Tomography Endpoint

    Measured: : Immediate postoperative, 1 year, 3 years

  14. Analysis of Vascular and scaffold morphology obtained with IVUS

    Intra-Vascular Ultrasound Endpoint

    Measured: Immediate postoperative,1 year, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start28 Mar 2018
  3. Primary completion30 Mar 2019 (estimated)
  4. Study completion30 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616132
Sponsor's protocol ID
IBS-FIM-MY
Status last verified
Jul 2018
First submitted
30 Jul 2018
Last updated
6 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System in people with Single Coronary Vessel Disease, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 2 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Xia (+86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Device related Composite Endpoint (Target Lesion Failure) (time frame: 1 month after implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03616132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.

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