ChampioNIR® SFA Stent EFS Study
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|ClinicalTrials.gov Identifier: NCT03775226|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: ChampioNIR® SFA Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients With Femoro-Popliteal Disease|
|Actual Study Start Date :||October 27, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||April 30, 2023|
Experimental: Single are
This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation.
Device: ChampioNIR® SFA Stent
The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.
Other Name: ChampioNIR®
- Primary patency of the target lesion at 6 months. [ Time Frame: 6 months ]Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) >2.4)
- Composite rate of freedom [ Time Frame: 30 Day ]from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.
- Primary patency defined by Duplex US [ Time Frame: 30 days and 12 months. ]Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4
- Acute device success [ Time Frame: index procedure ]defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.
- Acute procedural success [ Time Frame: index procedure ]defined as device success with <50% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.
- Acute technical success [ Time Frame: index procedure ]defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.
- Secondary Patency absence of restenosis which is defined as Duplex US [ Time Frame: 30 days 6, 12, 24 and 36 months ]Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)
- Combined rate 30 day [ Time Frame: 12 months ]of death at 30 days, target lesion revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)
- Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follow [ Time Frame: 30 days 6, 12, 24 and 36 months ]
- Type I - a single strut fracture only.
- Type II - multiple single nitinol stent fractures that can occur at different sites.
- Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.
- Type IV - a complete transverse linear type III fracture with stent displacement.
- Type V - a spiral dissection of a stent.
- Freedom from all-cause death, index limb amputation above the ankle and TVR. [ Time Frame: 30 days ]Clinical: The number of patients who die from all causes
- All-cause death [ Time Frame: 30 days, 6, 12, 24 and 36 months ]Clinical: The number of patients who die from all causes
- The following Major Adverse Limb Events will be evaluated either by angiography or clinical examination. These will be assessed by reviewing angiograms by the core-lab and clinical events will be adjudicated by a CEC [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
- Stent thrombosis
- Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene)
- Procedure-related arterial rupture
- Acute limb ischemia
- Target limb amputation
- Procedure related bleeding event requiring transfusion
These are clinical events, the unit of measure for all is - number of patients with any event
- Rutherford classification [ Time Frame: 30 days 6, 12, 24 and 36 months ]
Change of Rutherford classification from baseline
It is defined as follows, with increasing severity:
- - Mild Claudication - short duration
- - Moderate Claudication - moderate exercise
- - Severe Claudication - minor exertion
- - Rest Pain
- - Minor Tissue Loss
- - Major Tissue Loss
- resting ankle-brachial index [ Time Frame: 30 days 6, 12, 24 and 36 months ]
Change of resting ankle-brachial index (ABI) from baseline
Ankle Brachial Index (ABI) is a standard measure defined as:
The systolic blood pressure at the ankle divided by the systolic blood pressure at the upper arm (brachial artery) A ratio below 0.9 is considered significant
- walking impairment questionnaire [ Time Frame: 30 days 6, 12, 24 and 36 months ]Change in walking impairment questionnaire from baseline The questionnaire will be used to assess walking capability in patients with Peripheral Arterial Disease (to evaluate the walking impairment and the efficacy of an intervention to improve walking ability in patients with Peripheral Arterial Disease, PAD).\ The patients will be required to address their walking difficulties and grade them on an increased severity scale.
- six minute walk test [ Time Frame: 30 days 6, 12, 24 and 36 months ]Change in six minute walk test from baseline
- Amputation (above the ankle) [ Time Frame: 30 days, 6, 12, 24 and 36 months ]Amputation (above the ankle)-Free Survival (AFS)
- Target Vessel Revascularization [ Time Frame: 30 days, 6, 12, 24 and 36 months ]Target Vessel Revascularization (TVR) Will be measured by the number of patients with the event
- Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature [ Time Frame: 30 days, 6, 12, 24 and 36 months ]Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature Will be measured by the number of patients with the event
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775226
|Contact: Gali Vino||972-3-767-9000 ext 3258||galiv@MEDINOL.COM|
|Contact: Hila Ezra Altshuler||972-3-767-9000 ext 3369||hilae@MEDINOL.COM|
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