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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia (CLI)
• Intervention / Treatment: Device: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™); Device: Percutaneous Transluminal Angioplasty (PTA) Device

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Principal Investigator: Xuan Li
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Principal Investigator: Xiaoming Zhang
  • Beijing, China
    • Not yet recruiting
    • Beijing Hospital
    • Principal Investigator: Yongjun LI
  • Beijing, China
    • Not yet recruiting
    • Peking University First Hospital
  • Beijing, China
    • Not yet recruiting
    • Peking Union Medical College Hospital
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
  • Beijing, China
    • Not yet recruiting
    • Beijing Anzhen Hospital, Capital Medical University
    • Principal Investigator: Zhong Chen
  • Beijing, China
    • Not yet recruiting
    • Beijing Tsinghua Changgung Hospital
    • Principal Investigator: Weiwei Wu
  • Beijing, China
    • Recruiting
    • People's Liberation Army General Hospital
  • Beijing, China
    • Not yet recruiting
    • Xiyuan Hospital, China Academy of Chinese Medical Sciences
    • Principal Investigator: Baixi Zhuang
  • Changzhou, China
    • Recruiting
    • The First People's Hospital of Changzhou
    • Principal Investigator: Yunfeng Zhu
  • Chongqing, China
    • Recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Principal Investigator: Yu Zhao
  • Dalian, China
    • Not yet recruiting
    • The First Affiliated Hospital of Dalian Medical University
  • Fuzhou, China
    • Recruiting
    • The First Affiliated Hospital of Fujian Medical University
    • Principal Investigator: Pingfan Guo
  • Guangxi, China
    • Not yet recruiting
    • The First Affiliated Hospital of Guangxi Medical University
    • Principal Investigator: Xiao Qin
  • Hangzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Nanchang, China
    • Not yet recruiting
    • The Second Affiliated Hospital Of NanChang University
  • Nanjing, China
    • Not yet recruiting
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Nanjing, China
    • Not yet recruiting
    • The First Affiliated Hospital with Nanjing Medical University
    • Principal Investigator: Xiwei Zhang
  • Shanghai, China
    • Not yet recruiting
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
    • Principal Investigator: Lan Zhang
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Not yet recruiting
    • Zhongshan Hospital, Fudan University
  • Shenyang, China
    • Recruiting
    • ShengJing Hospital Of China Medical University
    • Principal Investigator: Zhaoyu Liu
  • Shijiazhuang, China
    • Not yet recruiting
    • The Second Hospital of Hebei Medical University
    • Principal Investigator: Wei Bi
  • Taiyuan, China
    • Recruiting
    • Second Hospital of Shanxi Medical University
    • Principal Investigator: Honglin Dong
  • Tianjin, China
    • Recruiting
    • General Hospital of Tianjin Medical University
  • Tianjin, China
    • Recruiting
    • Tianjin 4th Centre Hospital
    • Principal Investigator: Yidong Liu
  • Zhengzhou, China
    • Recruiting
    • Henan Provincial People's Hospital
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must between 18 and 85 years old, without gender limit.
2. 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.
3. Subject has lower extremity atherosclerotic occlusive disease with symptomatic Critical Limb Ischemia (CLI).
4. Rutherford Becker Clinical Category 3-5.
5. The target lesion is below the popliteal artery (including bifurcation).
6. The target lesion is located in the proximal 2/3 of native infrapopliteal vessels or tibiofibular trunk.
7. 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).
8. 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.

Exclusion Criteria:

1. Severe renal insufficiency, hepatic dysfunction (Cr>2 times of normal limit or renal dialysis, ALT or AST > 5 times of normal limit).
2. Surgery in target vessel before treatment.
3. Volume reduction surgery in target vessel before treatment.
4. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
5. Systematic coagulation disorder or hypercoagulability.
6. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
7. Stroke occurs within 3 months before surgery, or stroke occurs with severe hemiplegia aphasia sequelae more than 3 months before treatment.
8. Acute myocardial infarction or angina pectoris within 30 days before treatment.
9. In-stent restenosis.
10. Guide wire cannot pass target lesion.
11. Previously treated with drug eluting balloon within 1 year before treatment.
12. More than two infrapopliteal arteries needed treatment.
13. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis >30% with or without intervention.
14. The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has > 150 mm stenosis or occlusion before treatment.
15. Aneurysm of lower extremity artery.
16. Thromboangiitis obliterans (Buerger's disease).
17. 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.
18. 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.
19. Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
20. Patients who are participating in another clinical trial that has not yet completed its primary endpoint.
21. Pregnant or those who plan pregnancy during the clinical investigation follow-up period.
22. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
23. Patients have life expectancy ≤ 1 year.
24. Patients who are not suitable for participating the trial judged by investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBS Titan	Device: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™); Subjects in this arm will be treated with IBS Titan™.
Active Comparator: Percutaneous Transluminal Angioplasty (PTA)	Device: Percutaneous Transluminal Angioplasty (PTA) Device; Subjects in this arm will be treated with PTA device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		30 days, 180 days, 365 days
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.	30 days, 180 days, 365 days
Incidence of major amputation	Unplanned amputation of the lower limb above the ankle on the target lesion side	30 days, 180 days, 365 days
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.	Immediately after the procedure
Rate of Participants with Technical Success	Defined as restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <50%.	Immediately after the procedure
Rate of Participants with Procedural Success	Defined as the combination of technical success, device success, and absence of procedural complications.	Immediately after the procedure
Late Lumen Loss		180 days
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.	30 days, 180 days, 365 days
Change in ankle-brachial index (ABI) compared to baseline (before treatment)		30 days, 180 days, 365 days
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.	30 days, 180 days, 365 days
Wound healing rate of ulcer patients		30 days, 180 days, 365 days

Collaborators and Investigators

• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; 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-Titan-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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