Femoropopliteal Occlusive DiseaseNCT05082532
Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
A study testing Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) . in people with Femoropopliteal Occlusive Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Occlusive Disease
- What is being tested?
- Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2021to Sep 2025
- 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
- Patients with critical limb ischemia(grade 4,5\&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
- Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
- Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
- If the lesion extends to popliteal artey against knee flexion.
Who cannot join
- Pediatric patients.
- Patients with isolated infra-popliteal occlusion.
- Patients with popliteal blind segment with bad runoff.
- Patients with acute thrombotic occlusions.
- Patients with previous bypass surgery in affected limb.
- Patients with aneurysmal lesion in the affected limb.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut, +20
ahmed A hussein, ahmednaserhussein7@yahoo.com
About this study
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
Read the detailed description
Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.
- Conditions
- Femoropopliteal Occlusive Disease
- Being tested
- Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .Other
we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions.
| Study group | Role | What they receive |
|---|---|---|
| patients with critical and subcritical femoropopliteal arterial occlusions | Experimental | patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway. Receives: Other: Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging
Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Naser Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082532
- Sponsor's protocol ID
- SUPERA
- Status last verified
- Oct 2021
- First submitted
- 3 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II63-81. doi: 10.1583/08-2658.1.
PubMed 19624075
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Interwoven Self-Expandable Nitinol Stent for Femropopliteal Arterial Occlusive Diseases
- ClinicalTrials.gov ID
- NCT05082532
- Acronym / sponsor ID
- SUPERA
- Conditions
- Femoropopliteal Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Oct 2021 (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.
Interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.
Detailed description
Stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (PTA) or long lesion length. However, in-stent restenosis (ISR) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. Besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal Nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. Investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropopliteal complex occlusive lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with critical and subcritical femoropopliteal arterial occlusions | Experimental | Other: Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .patients presented with chronic ischemia in rest pain stage or ulcerative and gangrenous toes and by investigations long chronic total occlusion of femoropopliteal segment was documented may need stenting of the diseased segment especially if the lesion recoils after previous angioplasty. Nitinol interwoven stent has a unique design that achieves adherence to vessel wall and also malleability with the vessel and surrounding muscle motion so investigators predict more extended patency time with this interventional option and want to investigate this prediction using a scientific experimental pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with critical limb ischemia(grade 4,5\&6 Rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 Rutherford classification).
- Patients with chronic total occlusion(CTO) of femoropopliteal segment which is equal or beyond 10 centimeters length.
- Patients with recoil after transluminal angioplasty or occlusion in previously deployed stent.
- If the lesion extends to popliteal artey against knee flexion.
Key exclusion criteria (6 listed)
- Pediatric patients.
- Patients with isolated infra-popliteal occlusion.
- Patients with popliteal blind segment with bad runoff.
- Patients with acute thrombotic occlusions.
- Patients with previous bypass surgery in affected limb.
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 |
|---|---|---|
| Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) .we here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) in femoropoliteal complex occlusive lesions. | Other | patients with critical and subcritical femoropopliteal arterial occlusions |
Primary outcome
peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging
Time frame: 4 years
Crossing the lesion and deploying the stent without residual stenosis or degree of stenosis is less than 30% and assess the time the stent remains patent without re interventions. the outcome will be measured on clinical aspect and imaging aspect. Clinically ,investigators will trace the ankle brachial index (ankle systolic pressure relative to systemic systolic pressure), wound healing progress through cascade measuring of ulcer diameter in centimeters till complete healing and pain improvement depending on visual analogue score from 0 to 10.Imaging follow up, investigators will trace diseased segment diameters after intervention in millimeters and peak systolic velocity through the stent in centimeters per second.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 19624075Mewissen MW. Primary nitinol stenting for femoropopliteal disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II63-81. doi: 10.1583/08-2658.1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interwoven supera stent (IW; Supera Veritas®; Abbott Vascular, Santa Clara, CA, USA) . in people with Femoropopliteal Occlusive Disease, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed A hussein, master of vascular surgery (+20-088-0291608774, ahmednaserhussein7@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak systolic velocity in centimeters per second (cm/sec) through the deployed stent in serial duplex imaging (time frame: 4 years). 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 NCT05082532, which also lists 1 linked publication.
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 19 Oct 2021.