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Infrapopliteal LesionsNCT05971394

IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

A study testing Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in people with Infrapopliteal Lesions and Critical Limb Ischemia, run by Biotyx Medical (Shenzhen) Co., Ltd. at 1 site in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
17 Jul 2023to Jul 2026
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General criteria
  • Subject between 18 and 85 years old.
  • Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.
  • Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.
  • Subject requires primary treatment of de novo infrapopliteal lesions.
  • Angiographic criteria
Show all 12Show fewer
  • Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.
  • The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.
  • The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.
  • Only two infrapopliteal vessels are allowed to be treated at the same time.
  • A maximum of two stents can be deployed at one target vessel.
  • There must be at least one unimpaired artery (< 30% stenosis) to the ankle.

Who cannot join

  • General criteria：
  • Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or renal dialysis, ALT or AST > 5 times normal limit).
  • Major amputation before index procedure or plan for major amputation.
  • Any coagulation disorder.
  • Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
  • Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.
Show all 26Show fewer
  • Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.
  • Thromboangiitis obliterans (Buerger's disease).
  • Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.
  • Any surgery in target vessel before index procedure.
  • Volume reduction operation in target vessel before inclusion.
  • Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.
  • Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  • Women of child-bearing potential not using an effective contraception; pregnant or lactating women.
  • Subject is not suitable to participate in the trial as per investigators discretion.
  • Life expectancy ≤ 12 months as per investigators judgement.
  • Angiographic criteria
  • The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis >30% with or without intervention.
  • The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has > 150 mm stenosis or occlusion before treatment.
  • Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel.
  • In-stent restenosis in any lower extremity artery.
  • Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
  • Guide wire cannot pass target lesion.
  • Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
  • Aneurysm of lower extremity artery in the ipsilateral leg.

Trial locations and contacts

1 site in 1 country.

Ying Xia contact

0755 23221096

xiaying@lifetechmed.com

Italy1 site, 1 recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Florence

    Fabrizio Fanelli

    Recruiting

Other trials in Italy

About this study

Official title: A Prospective, Multicentre, Single Arm Clinical Trial to Assess the Safety and Effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in Treating Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease

The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.

Being tested
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Keywords
BTK, below-the-knee, Infrapopliteal lesions
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

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

  • Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)Device

    Subjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)

Study groups in NCT05971394
Study groupRoleWhat they receive
IBS TitanExperimentalSubjects treated with IBS Titan™.Participants will be included in this arm.
Receives: Device: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)

What is being measured

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

  1. Freedom from Primary Efficacy Failure

    Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.

    Measured: 6 months

Secondary outcomes (7)

  1. Major adverse event (MAE)

    Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.

    Measured: 1 month, 6 months, 12 months

  2. Rate of Device success

    Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.

    Measured: Immediately post-procedure

  3. Rate of Technical success

    Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <30%.

    Measured: Immediately post-procedure

  4. Rate of Procedural success

    Defined as the combination of technical success, device success, and absence of procedural complications.

    Measured: Immediately post-procedure

  5. Incidence of Target lesion restenosis

    Defined as peak systolic velocity ratio (PSVR) >2.4 by DUS.

    Measured: 1 month, 6 months, 12 months

  6. Change in ankle-brachial index (ABI) compared to baseline (before treatment)

    Change in Ankle Brachial Index (ABI) from pre-procedure. Larger values mean a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm.

    Measured: 1 month, 6 months, 12 months

  7. Change in Rutherford Category compared to baseline (before treatment)

    Categories and Clinical Description (higher scores mean a worse outcome):

    Category 0 = Asymptomatic, no hemodynamically significant occlusive disease, Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication, Category 4 = Ischemic rest pain, Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.

    Measured: 1 month, 6 months, 12 months

Timeline

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

  1. First posted2 Aug 2023
  2. Study start17 Jul 2023
  3. Primary completionJan 2026 (estimated)
  4. Study completionJul 2026 (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
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971394
Sponsor's protocol ID
BTK-01
Status last verified
Jul 2023
First submitted
15 Jul 2023
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in people with Infrapopliteal Lesions and Critical Limb Ischemia, run by Biotyx Medical (Shenzhen) Co., Ltd. at 1 site in Italy.

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 12 inclusion and 26 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 (0755 23221096, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from Primary Efficacy Failure (time frame: 6 months). 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 NCT05971394.

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 2 Aug 2023.

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