Clinical trial NCT04849325: IBS Titan vs. PTA in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Limb Ischemia (CLI)
Lead sponsor: Biotyx Medical (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Primary Patency Rate
timeFrame: 180 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days, 180 days, 365 days
measure: Incidence of Clinically-driven Target Vessel Revascularization (CD-TLR)
timeFrame: 30 days, 180 days, 365 days
measure: Incidence of major amputation
timeFrame: 30 days, 180 days, 365 days
measure: Rate of Device Success
timeFrame: Immediately after the procedure
measure: Rate of Participants with Technical Success
timeFrame: Immediately after the procedure
measure: Rate of Participants with Procedural Success
timeFrame: Immediately after the procedure
measure: Late Lumen Loss
timeFrame: 180 days
measure: Incidence of Target lesion restenosis
timeFrame: 30 days, 180 days, 365 days
measure: Change in ankle-brachial index (ABI) compared to baseline (before treatment)
timeFrame: 30 days, 180 days, 365 days
measure: Change in Rutherford-Becker category compared to baseline (before treatment)
timeFrame: 30 days, 180 days, 365 days
measure: Wound healing rate of ulcer patients
timeFrame: 30 days, 180 days, 365 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: People's Liberation Army General Hospital
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangxi
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
city: Tianjin
country: China
facility: Tianjin 4th Centre Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: