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IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

Primary Purpose

Infrapopliteal Lesions, Critical Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Sponsored by
Biotyx Medical (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infrapopliteal Lesions focused on measuring BTK, below-the-knee, Infrapopliteal lesions

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • General criteria Subject between 18 and 85 years old. Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5. Subject requires primary treatment of de novo infrapopliteal lesions. • Angiographic criteria Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm. Only two infrapopliteal vessels are allowed to be treated at the same time. A maximum of two stents can be deployed at one target vessel. There must be at least one unimpaired artery (< 30% stenosis) to the ankle. Exclusion Criteria: • General criteria: Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or renal dialysis, ALT or AST > 5 times normal limit). Major amputation before index procedure or plan for major amputation. Any coagulation disorder. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study. Thromboangiitis obliterans (Buerger's disease). Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion. Any surgery in target vessel before index procedure. Volume reduction operation in target vessel before inclusion. Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy. Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Women of child-bearing potential not using an effective contraception; pregnant or lactating women. Subject is not suitable to participate in the trial as per investigators discretion. Life expectancy ≤ 12 months as per investigators judgement. • Angiographic criteria 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. Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel. In-stent restenosis in any lower extremity artery. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy. Guide wire cannot pass target lesion. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed. Aneurysm of lower extremity artery in the ipsilateral leg.

Sites / Locations

  • Azienda Ospedaliero Universitaria CareggiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IBS Titan

Arm Description

Subjects treated with IBS Titan™.Participants will be included in this arm.

Outcomes

Primary Outcome Measures

Freedom from Primary Efficacy Failure
Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.

Secondary Outcome Measures

Major adverse event (MAE)
Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.
Rate of Device success
Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.
Rate of Technical success
Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <30%.
Rate of Procedural success
Defined as the combination of technical success, device success, and absence of procedural complications.
Incidence of Target lesion restenosis
Defined as peak systolic velocity ratio (PSVR) >2.4 by DUS.
Change in ankle-brachial index (ABI) compared to baseline (before treatment)
Change in Ankle Brachial Index (ABI) from pre-procedure. Larger values mean a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
Change in Rutherford 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.

Full Information

First Posted
July 15, 2023
Last Updated
July 31, 2023
Sponsor
Biotyx Medical (Shenzhen) Co., Ltd.
Collaborators
VascuScience GmbH, Mediolanum Cardio Research Srl, Euroimage Research Srl
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1. Study Identification

Unique Protocol Identification Number
NCT05971394
Brief Title
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
Official Title
A Prospective, Multicentre, Single Arm Clinical 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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotyx Medical (Shenzhen) Co., Ltd.
Collaborators
VascuScience GmbH, Mediolanum Cardio Research Srl, Euroimage Research Srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this prospective, multicentre, single arm clinical trial is 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. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infrapopliteal Lesions, Critical Limb Ischemia
Keywords
BTK, below-the-knee, Infrapopliteal lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBS Titan
Arm Type
Experimental
Arm Description
Subjects treated with IBS Titan™.Participants will be included in this arm.
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Intervention Description
Subjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Primary Outcome Measure Information:
Title
Freedom from Primary Efficacy Failure
Description
Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Major adverse event (MAE)
Description
Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.
Time Frame
1 month, 6 months, 12 months
Title
Rate of Device success
Description
Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.
Time Frame
Immediately post-procedure
Title
Rate of Technical success
Description
Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis <30%.
Time Frame
Immediately post-procedure
Title
Rate of Procedural success
Description
Defined as the combination of technical success, device success, and absence of procedural complications.
Time Frame
Immediately post-procedure
Title
Incidence of Target lesion restenosis
Description
Defined as peak systolic velocity ratio (PSVR) >2.4 by DUS.
Time Frame
1 month, 6 months, 12 months
Title
Change in ankle-brachial index (ABI) compared to baseline (before treatment)
Description
Change in Ankle Brachial Index (ABI) from pre-procedure. Larger values mean a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm.
Time Frame
1 month, 6 months, 12 months
Title
Change in Rutherford Category compared to baseline (before treatment)
Description
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.
Time Frame
1 month, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • General criteria Subject between 18 and 85 years old. Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5. Subject requires primary treatment of de novo infrapopliteal lesions. • Angiographic criteria Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm. Only two infrapopliteal vessels are allowed to be treated at the same time. A maximum of two stents can be deployed at one target vessel. There must be at least one unimpaired artery (< 30% stenosis) to the ankle. Exclusion Criteria: • General criteria: Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or renal dialysis, ALT or AST > 5 times normal limit). Major amputation before index procedure or plan for major amputation. Any coagulation disorder. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study. Thromboangiitis obliterans (Buerger's disease). Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion. Any surgery in target vessel before index procedure. Volume reduction operation in target vessel before inclusion. Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy. Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Women of child-bearing potential not using an effective contraception; pregnant or lactating women. Subject is not suitable to participate in the trial as per investigators discretion. Life expectancy ≤ 12 months as per investigators judgement. • Angiographic criteria 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. Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel. In-stent restenosis in any lower extremity artery. Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy. Guide wire cannot pass target lesion. Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed. Aneurysm of lower extremity artery in the ipsilateral leg.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xia
Phone
0755 23221096
Email
xiaying@lifetechmed.com
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Florence
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Fanelli

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

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