Peripheral Arterial DiseaseNCT03775226

ChampioNIR® SFA Stent EFS Study

A study testing ChampioNIR® SFA Stent in people with Peripheral Arterial Disease, run by Medinol Ltd. at 3 sites in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: ChampioNIR® SFA Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 3 sitesIsrael
Study dates: 27 Oct 2019to 30 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years and of age of legal consent.
Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
A single superficial femoral artery lesion with >50% stenosis or total occlusion.
Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.
Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).

Show all 10Show fewer

Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
The target lesion(s) can be successfully crossed with a guide wire and dilated.
The subject is eligible for standard surgical repair, if necessary.
Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.

Who cannot join

Thrombophlebitis or deep venous thrombus, within the previous 30 days.
Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion.
Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
Presence of an ipsilateral arterial artificial graft.

Show all 31Show fewer

Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
Required stent placement (in the target or any other lesion) via a retrograde approach.
Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
Stroke within the previous 90 days.
Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.
Receiving dialysis or immunosuppressant therapy within the previous 30 days.
Known or suspected active infection at the time of the procedure.
History of neutropenia, coagulopathy, or thrombocytopenia.
Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
Platelet count <80,000/μL
International normalized ratio (INR) > 1.5
GFR <30 ml/min by Cockroft-Gault.
Subject requires general anesthesia for the procedure.
Subject has a co-morbid illness that may result in a life expectancy of less than 1 year
Planned use of a drug coated balloon (DCB) during the index procedure.
Pregnant women or women of child bearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
Subject is participating in any investigational study that has not yet reached its primary endpoint.

Trial locations and contacts

3 sites in 1 country.

Israel3 sites

Hadassah Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Sourasky Medical Center
Tel Aviv

Other trials in Israel

About this study

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

An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease

Read the detailed description

Device Overview:

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.

Objectives:

To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA Stent.
To assess the early and long term ability of the stent to maintain vessel patency.
To assess the long term safety of the ChampioNIR® SFA Stent.

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. All enrolled patients will be followed up at 30 days and up to 36 months. The follow-up visits will include patency evaluation by duplex ultrasound.

Primary efficacy endpoint: Primary patency of the target lesion at 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) Primary safety endpoint: Composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.

Secondary efficacy endpoints:

Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4) at 30 days and 12 months.
Acute device success, defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.
Acute procedural success, 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, defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.
The following endpoints at 30 days 6, 12, 24 and 36 months:

Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)
Change of Rutherford classification from baseline
Change of resting ankle-brachial index (ABI) from baseline
Change in walking impairment questionnaire from baseline
Change in six minute walk test from baseline

Secondary safety endpoints:

Combined rate 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) throughout 12 months.
Stent fracture at 30 days 6, 12, 24 and 36 months. 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 follows:

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 at 30 days from all-cause death, index limb amputation above the ankle and TVR.
The following endpoints will be assessed at 30 days, 6, 12, 24 and 36 months:
All-cause death
Amputation (above the ankle)-Free Survival (AFS)
Target Vessel Revascularization (TVR)
Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
Major Adverse Limb Events (MALE) at 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

Sample Size and Statistical Analysis:

The study is an early feasibility study and is not powered towards finding significant differences in the primary endpoints. The sample size of up to 30 patients will allow for the evaluation of feasibility and safety of the procedure, to support the initiation of a pivotal study. No formal statistical power calculations were conducted.

Conditions: Peripheral Arterial Disease
Being tested: ChampioNIR® SFA Stent
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChampioNIR® SFA StentDevice
Also called ChampioNIR®
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.

Study groups in NCT03775226
Study group	Role	What they receive
Single are	Experimental	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. Receives: Device: ChampioNIR® SFA Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary patency of the target lesion at 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)
Measured: 6 months
Composite rate of freedom
from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.
Measured: 30 Day

Secondary outcomes (17)

Primary patency defined by Duplex US
Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4
Measured: 30 days and 12 months.
Acute device success
defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.
Measured: index procedure
Acute procedural success
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.
Measured: index procedure
Acute technical success
defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.
Measured: index procedure
Secondary Patency absence of restenosis which is defined as Duplex US
Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)
Measured: 30 days 6, 12, 24 and 36 months
Combined rate 30 day
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)
Measured: 12 months
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
- 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.
Measured: 30 days 6, 12, 24 and 36 months
Freedom from all-cause death, index limb amputation above the ankle and TVR.
Clinical: The number of patients who die from all causes
Measured: 30 days
All-cause death
Clinical: The number of patients who die from all causes
Measured: 30 days, 6, 12, 24 and 36 months
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
1. Stent thrombosis
2. Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene)
3. Procedure-related arterial rupture
4. Acute limb ischemia
5. Target limb amputation
6. Procedure related bleeding event requiring transfusion
These are clinical events, the unit of measure for all is - number of patients with any event
Measured: 30 days, 6, 12, 24 and 36 months
Rutherford classification
Change of Rutherford classification from baseline
It is defined as follows, with increasing severity:
1. - Mild Claudication - short duration
2. - Moderate Claudication - moderate exercise
3. - Severe Claudication - minor exertion
4. - Rest Pain
5. - Minor Tissue Loss
6. - Major Tissue Loss
Measured: 30 days 6, 12, 24 and 36 months
resting ankle-brachial index
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
Measured: 30 days 6, 12, 24 and 36 months
walking impairment questionnaire
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.
Measured: 30 days 6, 12, 24 and 36 months
six minute walk test
Change in six minute walk test from baseline
Measured: 30 days 6, 12, 24 and 36 months
Amputation (above the ankle)
Amputation (above the ankle)-Free Survival (AFS)
Measured: 30 days, 6, 12, 24 and 36 months
Target Vessel Revascularization
Target Vessel Revascularization (TVR) Will be measured by the number of patients with the event
Measured: 30 days, 6, 12, 24 and 36 months
Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
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
Measured: 30 days, 6, 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 201930 Jan 2023

First posted13 Dec 2018
Study start27 Oct 2019
Primary completion26 Aug 2021
Study completion30 Jan 2023

Why it stopped: The study objective was achieved. Patients are no longer being examined or receiving intervention.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03775226
Sponsor's protocol ID: SFA-Israel-001
Status last verified: Oct 2023
First submitted: 21 Nov 2018
Last updated: 3 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03775226
Acronym / sponsor ID: SFA-Israel-001
Conditions: Peripheral Arterial Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study objective was achieved. Patients are no longer being examined or receiving intervention.
Enrolment: 22 participants (actual)
Lead sponsor: Medinol Ltd.Industry (pharma, biotech, devices)
Study start: 27 Oct 2019 (actual)
Primary completion: 26 Aug 2021 (actual)
Study completion: 30 Jan 2023 (actual)
First posted: 13 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease

Detailed description

Device Overview:

Objectives:

To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA Stent.
To assess the early and long term ability of the stent to maintain vessel patency.
To assess the long term safety of the ChampioNIR® SFA Stent.

Secondary efficacy endpoints:

Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4) at 30 days and 12 months.
Acute device success, defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.
Acute procedural success, 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, defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.
The following endpoints at 30 days 6, 12, 24 and 36 months:

Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)
Change of Rutherford classification from baseline
Change of resting ankle-brachial index (ABI) from baseline
Change in walking impairment questionnaire from baseline
Change in six minute walk test from baseline

Secondary safety endpoints:

Combined rate 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) throughout 12 months.
Stent fracture at 30 days 6, 12, 24 and 36 months. 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 follows:

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 at 30 days from all-cause death, index limb amputation above the ankle and TVR.
The following endpoints will be assessed at 30 days, 6, 12, 24 and 36 months:
All-cause death
Amputation (above the ankle)-Free Survival (AFS)
Target Vessel Revascularization (TVR)
Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
Major Adverse Limb Events (MALE) at 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

Sample Size and Statistical Analysis:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single are	Experimental	Device: ChampioNIR® SFA StentThis 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥ 18 years and of age of legal consent.
Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
A single superficial femoral artery lesion with >50% stenosis or total occlusion.
Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.

Key exclusion criteria (31 listed)

Thrombophlebitis or deep venous thrombus, within the previous 30 days.
Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion.
Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChampioNIR® SFA StentAlso: ChampioNIR®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.	Device	Single are

Primary outcome

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.

17 secondary outcomes

Primary patency defined by Duplex US
Time frame: 30 days and 12 months.
Acute device success
Time frame: index procedure
Acute procedural success
Time frame: index procedure
Acute technical success
Time frame: index procedure
Secondary Patency absence of restenosis which is defined as Duplex US
Time frame: 30 days 6, 12, 24 and 36 months
Combined rate 30 day
Time frame: 12 months
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
Freedom from all-cause death, index limb amputation above the ankle and TVR.
Time frame: 30 days
All-cause death
Time frame: 30 days, 6, 12, 24 and 36 months
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
Rutherford classification
Time frame: 30 days 6, 12, 24 and 36 months
resting ankle-brachial index
Time frame: 30 days 6, 12, 24 and 36 months
walking impairment questionnaire
Time frame: 30 days 6, 12, 24 and 36 months
six minute walk test
Time frame: 30 days 6, 12, 24 and 36 months
Amputation (above the ankle)
Time frame: 30 days, 6, 12, 24 and 36 months
Target Vessel Revascularization
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
Time frame: 30 days, 6, 12, 24 and 36 months

Results and safety

The study was stopped early (reason given: The study objective was achieved. Patients are no longer being examined or receiving intervention.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Individual participant dataSharing planned: Undecided

Related trials for Peripheral Arterial Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ChampioNIR® SFA Stent in people with Peripheral Arterial Disease, run by Medinol Ltd. at 3 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study objective was achieved. Patients are no longer being examined or receiving intervention.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary patency of the target lesion at 6 months. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03775226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.