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

Critical Limb Ischemia (CLI) Clinical Trial

— GENIUS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849325
• Other study ID #: IBS-Titan-01
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: October 2024

Study information

• Verified date: March 2022
• Source: Biotyx Medical (Shenzhen) Co., Ltd.
• Contact: Ying Xia
• Phone: 86 13760184511
• Email: xiaying[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Limb Ischemia (CLI)
• Ischemia

Intervention

Device:
• Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Subjects in this arm will be treated with IBS Titan™.
• Percutaneous Transluminal Angioplasty (PTA) Device
Subjects in this arm will be treated with PTA device.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	People's Liberation Army General Hospital	Beijing
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First People's Hospital of Changzhou	Changzhou
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou
China	The First Affiliated Hospital of Guangxi Medical University	Guangxi
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School	Nanjing
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	The Second Hospital of Hebei Medical University	Shijiazhuang
China	Second Hospital of Shanxi Medical University	Taiyuan
China	General Hospital of Tianjin Medical University	Tianjin
China	Tianjin 4th Centre Hospital	Tianjin
China	Henan Provincial People's Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality		30 days, 180 days, 365 days
Secondary	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
Secondary	Incidence of major amputation	Unplanned amputation of the lower limb above the ankle on the target lesion side	30 days, 180 days, 365 days
Secondary	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
Secondary	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
Secondary	Rate of Participants with Procedural Success	Defined as the combination of technical success, device success, and absence of procedural complications.	Immediately after the procedure
Secondary	Late Lumen Loss		180 days
Secondary	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
Secondary	Change in ankle-brachial index (ABI) compared to baseline (before treatment)		30 days, 180 days, 365 days
Secondary	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
Secondary	Wound healing rate of ulcer patients		30 days, 180 days, 365 days