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

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

Sponsors

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

Source Biotyx Medical (Shenzhen) Co., Ltd.
Brief 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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2024-09-01
Primary Completion Date 2024-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary Patency Rate 180 days
Secondary Outcome
Measure Time Frame
All-cause mortality 30 days, 180 days, 365 days
Incidence of Clinically-driven Target Vessel Revascularization (CD-TLR) 30 days, 180 days, 365 days
Incidence of major amputation 30 days, 180 days, 365 days
Rate of Device Success Immediately after the procedure
Rate of Participants with Technical Success Immediately after the procedure
Rate of Participants with Procedural Success Immediately after the procedure
Late Lumen Loss 180 days
Incidence of Target lesion restenosis 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) 30 days, 180 days, 365 days
Wound healing rate of ulcer patients 30 days, 180 days, 365 days
Enrollment 120
Condition
Intervention

Intervention Type: Device

Intervention Name: Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)

Description: Subjects in this arm will be treated with IBS Titan™.

Arm Group Label: IBS Titan

Intervention Type: Device

Intervention Name: Percutaneous Transluminal Angioplasty (PTA) Device

Description: Subjects in this arm will be treated with PTA device.

Arm Group Label: Percutaneous Transluminal Angioplasty (PTA)

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Ying Xia

Phone: 86 13760184511

Email: [email protected]

Location
Facility: Investigator:
Beijing Anzhen Hospital, Capital Medical University | Beijing, China Zhong Chen Principal Investigator
Beijing Hospital | Beijing, China Yongjun Li Principal Investigator
Beijing Tsinghua Changgung Hospital | Beijing, China Weiwei Wu Principal Investigator
Peking Union Medical College Hospital | Beijing, China Yuehong Zheng Principal Investigator
Peking University First Hospital | Beijing, China Yinghua Zou Principal Investigator
Peking University People's Hospital | Beijing, China Xiaoming Zhang Principal Investigator
Peking University Third Hospital | Beijing, China Xuan Li Principal Investigator
People's Liberation Army General Hospital | Beijing, China Wei Guo Principal Investigator
Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing, China Baixi Zhuang Principal Investigator
Xuanwu Hospital, Capital Medical University | Beijing, China Lianrui Guo Principal Investigator
The First People's Hospital of Changzhou | Changzhou, China Yunfeng Zhu Principal Investigator
The First Affiliated Hospital of Chongqing Medical University | Chongqing, China Yu Zhao Principal Investigator
The First Affiliated Hospital of Dalian Medical University | Dalian, China Feng Wang Principal Investigator
The First Affiliated Hospital of Fujian Medical University | Fuzhou, China Pingfan Guo Principal Investigator
The First Affiliated Hospital of Guangxi Medical University | Guangxi, China Xiao Qin Principal Investigator
The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, China Hongkun Zhang Principal Investigator
The Second Affiliated Hospital of Nanchang University | Nanchang, China Weimin Zhou Principal Investigator
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Nanjing, China Xiaoqiang Li Principal Investigator
The First Affiliated Hospital with Nanjing Medical University | Nanjing, China Xiwei Zhang Principal Investigator
Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai, China Lan Zhang Principal Investigator
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | Shanghai, China Xinwu Lu Principal Investigator
Zhongshan Hospital, Fudan University | Shanghai, China Weiguo Fu Principal Investigator
Shengjing Hospital of China Medical University | Shenyang, China Zhaoyu Liu Principal Investigator
The Second Hospital of Hebei Medical University | Shijiazhuang, China Wei Bi Principal Investigator
Second Hospital of Shanxi Medical University | Taiyuan, China Honglin Dong Principal Investigator
General Hospital of Tianjin Medical University | Tianjin, China Xiangchen Dai Principal Investigator
Tianjin 4th Centre Hospital | Tianjin, China Yidong Liu Principal Investigator
Henan Provincial People's Hospital | Zhengzhou, China Shuiting Zhai Principal Investigator
The First Affiliated Hospital of Zhengzhou University | Zhengzhou, China Zhen Li Principal Investigator
Location Countries

China

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: IBS Titan

Type: Experimental

Label: Percutaneous Transluminal Angioplasty (PTA)

Type: Active Comparator

Acronym GENIUS
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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