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
1 other identifier
interventional
120
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 17, 2022
March 1, 2022
2.3 years
April 14, 2021
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (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.
180 days
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
IBS Titan
EXPERIMENTALPercutaneous Transluminal Angioplasty (PTA)
ACTIVE COMPARATORInterventions
Subjects in this arm will be treated with IBS Titan™.
Subjects in this arm will be treated with PTA device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 19, 2021
Study Start
December 9, 2021
Primary Completion
April 1, 2024
Study Completion
October 1, 2024
Last Updated
March 17, 2022
Record last verified: 2022-03