Peripheral Arterial DiseaseNCT04123639
Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis
A study testing PTA in people with Peripheral Arterial Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting . Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- PTA
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Oct 2022
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with PAD undergoing peripheral vascular intervention with SFA in stent stenosis for two years from the start of study and has critical limb ischemia.
Who cannot join
- Refusal of the patients
Trial locations and contacts
1 site in 1 country.
16 contact
About this study
Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting .
Atherosclerotic disease in the femoropopliteal (FP) artery consists of perfusion to the legs and feet. Percutaneous transluminal angioplasty (PTA) has been routinely used to manage FP artery disease and is recommended as an alternative to surgical bypass. Recently, newer endovascular approaches such as covered stent, drug-eluting balloon (DEB), drug-eluting stent (DES), or catheter based atherectomy have been introduced as treatment options for FP artery disease. Nevertheless, FP artery-in stent restenosis (ISR) is still a major challenge with endovascular therapy .
Read more
Although the use of peripheral arterial stents brought about a dramatic improvement in patients' clinical and procedural outcomes, the long-term outcome of stent implantation remains significantly constrained by the risk of developing in-stent restenosis (ISR) over time.
Advancements in endovascular stent technology have addressed limitations associated with conventional percutaneous transluminal balloon angioplasty in patients with chronic peripheral arterial disease (PAD) of the lower limbs, such as elastic recoil,residual stenosis and flow-limiting dissection . However, a considerable proportion of patients with PAD treated with stenting will require secondary interventions due to in-stent restenosis (ISR), which is particularly common in long and complex lesions ISR refers to loss of luminal volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of the stented artery and 5-mm margins proximal and distal to the stent. ISR has been reported to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the first year of treatment .
The treatment of ISR is one of the major challenges in endovascular therapy for PAD. The treatment options for ISR include standard balloon angioplasty with or without repeat stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .
- Conditions
- Peripheral Arterial Disease
- Being tested
- PTA
- 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.
PTAProcedure or surgery
Percutaneous transluminal angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Change number of superficial femoral artery in stent restenosis
Change number of superficial femoral artery in stent restenosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Malak Mahrous, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123639
- Sponsor's protocol ID
- 16
- Status last verified
- Oct 2019
- First submitted
- 6 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis
- ClinicalTrials.gov ID
- NCT04123639
- Acronym / sponsor ID
- 16
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 11 Oct 2019 (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.
Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting .
Atherosclerotic disease in the femoropopliteal (FP) artery consists of perfusion to the legs and feet. Percutaneous transluminal angioplasty (PTA) has been routinely used to manage FP artery disease and is recommended as an alternative to surgical bypass. Recently, newer endovascular approaches such as covered stent, drug-eluting balloon (DEB), drug-eluting stent (DES), or catheter based atherectomy have been introduced as treatment options for FP artery disease. Nevertheless, FP artery-in stent restenosis (ISR) is still a major challenge with endovascular therapy .
Although the use of peripheral arterial stents brought about a dramatic improvement in patients' clinical and procedural outcomes, the long-term outcome of stent implantation remains significantly constrained by the risk of developing in-stent restenosis (ISR) over time.
Advancements in endovascular stent technology have addressed limitations associated with conventional percutaneous transluminal balloon angioplasty in patients with chronic peripheral arterial disease (PAD) of the lower limbs, such as elastic recoil,residual stenosis and flow-limiting dissection . However, a considerable proportion of patients with PAD treated with stenting will require secondary interventions due to in-stent restenosis (ISR), which is particularly common in long and complex lesions ISR refers to loss of luminal volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of the stented artery and 5-mm margins proximal and distal to the stent. ISR has been reported to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the first year of treatment .
The treatment of ISR is one of the major challenges in endovascular therapy for PAD. The treatment options for ISR include standard balloon angioplasty with or without repeat stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PAD undergoing peripheral vascular intervention with SFA in stent stenosis for two years from the start of study and has critical limb ischemia.
Key exclusion criteria (1 listed)
- Refusal of the patients
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 |
|---|---|---|
| PTAPercutaneous transluminal angioplasty | Procedure or surgery | – |
Primary outcome
Change number of superficial femoral artery in stent restenosis
Time frame: 3 years
Change number of superficial femoral artery in stent restenosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- 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.
16 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA in people with Peripheral Arterial 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 1 inclusion and 1 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 11 Oct 2019. 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 16 (+201024699495, zekomessi16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change number of superficial femoral artery in stent restenosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2019.