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Critical Limb Ischemia (CLI)GENIUSNCT04849325

IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease

A study testing Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia (CLI), run by Biotyx Medical (Shenzhen) Co., Ltd. at 29 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A prospective, multi-center, randomized 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Critical Limb Ischemia (CLI)
What is being tested?
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) and Percutaneous Transluminal Angioplasty (PTA) Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
29 sitesChina
Study dates
9 Dec 2021to Oct 2024
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

  • Patients must between 18 and 85 years old, without gender limit.
  • Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and complete the 1-year follow-up.
  • Subject has lower extremity atherosclerotic occlusive disease with symptomatic Critical Limb Ischemia (CLI).
  • Rutherford Becker Clinical Category 3-5.
  • The target lesion is below the popliteal artery (including bifurcation).
  • The target lesion is located in the proximal 2/3 of native infrapopliteal vessels or tibiofibular trunk.
  • The target lesion stenosis is ≥70% or occlusion of no more than two infrapopliteal arteries (including the anterior and/or posterior tibial and/or peroneal artery and/or tibiofibular trunk).
  • The length of target lesion is ≤200mm, which could be covered by no more than two stents, with vessel diameter of 2.25-4.25 mm.

Who cannot join

  • Severe renal insufficiency, hepatic dysfunction (Cr>2 times of normal limit or renal dialysis, ALT or AST > 5 times of normal limit).
  • Surgery in target vessel before treatment.
  • Volume reduction surgery in target vessel before treatment.
  • Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
  • Systematic coagulation disorder or hypercoagulability.
  • Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
Show all 24Show fewer
  • Stroke occurs within 3 months before surgery, or stroke occurs with severe hemiplegia aphasia sequelae more than 3 months before treatment.
  • Acute myocardial infarction or angina pectoris within 30 days before treatment.
  • In-stent restenosis.
  • Guide wire cannot pass target lesion.
  • Previously treated with drug eluting balloon within 1 year before treatment.
  • More than two infrapopliteal arteries needed treatment.
  • 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.
  • Aneurysm of lower extremity artery.
  • Thromboangiitis obliterans (Buerger's disease).
  • Significant (≥ 50% stenosis) lesion in a distal outflow artery that would be perfused by the target vessel and that requires treatment at the time of the index procedure.
  • Patients known to be allergic to aspirin, heparin, Plavix, contrast agents, Sirolimus, poly lactic acid polymer, iron, zinc and their degradation product, and those who cannot tolerate postoperative dual anti-platelet therapy.
  • Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
  • Patients who are participating in another clinical trial that has not yet completed its primary endpoint.
  • Pregnant or those who plan pregnancy during the clinical investigation follow-up period.
  • Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
  • Patients have life expectancy ≤ 1 year.
  • Patients who are not suitable for participating the trial judged by investigator.

Trial locations and contacts

29 sites in 1 country.

Ying Xia contact

86 13760184511

xiaying@lifetechmed.com

29 sites in 1 country

China29 sites, 29 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

    Zhong Chen

    Not yet recruiting

  • Beijing Hospital

    Beijing

    Yongjun Li

    Not yet recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing

    Weiwei Wu

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing

    Yuehong Zheng

    Not yet recruiting

  • Peking University First Hospital

    Beijing

    Yinghua Zou

    Not yet recruiting

  • Peking University People's Hospital

    Beijing

    Xiaoming Zhang

    Recruiting

  • Peking University Third Hospital

    Beijing

    Xuan Li

    Recruiting

  • People's Liberation Army General Hospital

    Beijing

    Wei Guo

    Recruiting

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing

    Baixi Zhuang

    Not yet recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing

    Lianrui Guo

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    Yunfeng Zhu

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Yu Zhao

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Feng Wang

    Not yet recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

    Pingfan Guo

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi

    Xiao Qin

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Hongkun Zhang

    Not yet recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Weimin Zhou

    Not yet recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing

    Xiaoqiang Li

    Not yet recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing

    Xiwei Zhang

    Not yet recruiting

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Lan Zhang

    Not yet recruiting

  • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Xinwu Lu

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai

    Weiguo Fu

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang

    Zhaoyu Liu

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

    Wei Bi

    Not yet recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan

    Honglin Dong

    Recruiting

  • General Hospital of Tianjin Medical University

    Tianjin

    Xiangchen Dai

    Recruiting

  • Tianjin 4th Centre Hospital

    Tianjin

    Yidong Liu

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou

    Shuiting Zhai

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Zhen Li

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-Center, Randomized Trial Comparing the IBS Titan™ Sirolimus-Eluting Iron Bioresorbable Peripheral Scaffold System vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee Arteries: GENIUS TRIAL

A prospective, multi-center, randomized 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.

Being tested
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™), Percutaneous Transluminal Angioplasty (PTA) Device
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 IBS Titan™.

  • Percutaneous Transluminal Angioplasty (PTA) DeviceDevice

    Subjects in this arm will be treated with PTA device.

Study groups in NCT04849325
Study groupRoleWhat they receive
IBS TitanExperimentalNot described
Receives: Device: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Percutaneous Transluminal Angioplasty (PTA)Active comparatorNot described
Receives: Device: Percutaneous Transluminal Angioplasty (PTA) Device

What is being measured

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

  1. Primary Patency Rate

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

    Measured: 180 days

Secondary outcomes (11)

  1. All-cause mortality

    Measured: 30 days, 180 days, 365 days

  2. Incidence of Clinically-driven Target Vessel Revascularization (CD-TLR)

    CD-TLR is defined as any TLR of target lesions associated with Rutherford category exacerbation and/or increasing in the size of preexisting wounds and/or the occurrence of new wounds.

    Measured: 30 days, 180 days, 365 days

  3. Incidence of major amputation

    Unplanned amputation of the lower limb above the ankle on the target lesion side

    Measured: 30 days, 180 days, 365 days

  4. Rate of Device Success

    Device success is defined on a per device basis, 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 after the procedure

  5. Rate of Participants with Technical Success

    Defined as restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <50%.

    Measured: Immediately after the procedure

  6. Rate of Participants with Procedural Success

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

    Measured: Immediately after the procedure

  7. Late Lumen Loss

    Measured: 180 days

  8. Incidence of Target lesion restenosis

    Defined as a reduction in the luminal diameter >50% by angiography or CTA within the treated lesion plus the 5-mm segments proximal and distal to it or, as a peak systolic velocity ratio (PSVR) >2.4 by DUS.

    Note 1: Doppler ultrasound will be performed at 30 days and 365 days, DSA angiography will be performed 180 days.

    Note 2: If the patient presented with CD-TLR in advance, i.e. the patient reached the endpoint in advance, the restenosis before reintervention was assessed.

    Measured: 30 days, 180 days, 365 days

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

    Measured: 30 days, 180 days, 365 days

  10. Change in Rutherford-Becker 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: 30 days, 180 days, 365 days

  11. Wound healing rate of ulcer patients

    Measured: 30 days, 180 days, 365 days

Timeline

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

  1. First posted19 Apr 2021
  2. Study start9 Dec 2021
  3. Primary completionApr 2024 (estimated)
  4. Study completionOct 2024 (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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849325
Sponsor's protocol ID
IBS-Titan-01
Acronym
GENIUS
Status last verified
Mar 2022
First submitted
14 Apr 2021
Last updated
17 Mar 2022
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™) and Percutaneous Transluminal Angioplasty (PTA) Device in people with Critical Limb Ischemia (CLI), run by Biotyx Medical (Shenzhen) Co., Ltd. at 29 sites in China.

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 8 inclusion and 24 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. 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?

Primary Patency Rate (time frame: 180 days). 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 NCT04849325.

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 17 Mar 2022.

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