Critical Limb IschemiaNCT04974905
Retrograde Recanalization of Infrainguinal Arterial Occlusive Disease.
A study testing retrograde access for re-canalization of infra-inguinal arterial occlusive disease in people with Critical Limb Ischemia, run by Sohag University.
Trial summary
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption. Read more about this study
- Who is it for?
- Ages 35 to 95 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- retrograde access for re-canalization of infra-inguinal arterial occlusive disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 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 35 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with;
- CLI consistent with Rutherford categories (4-5).
- Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.
Who cannot join
- patients with the following conditions will be excluded:
- Non-salvageable limbs.
- Life threatening infections requiring major amputation.
- Ulcers at the area of intended puncture.
Trial locations and contacts
No sites are listed yet.
Hussein K Hussein, Professor contact
About this study
Official title: Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.
Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.
Read more
Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.
Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.
- Conditions
- Critical Limb Ischemia
- Being tested
- retrograde access for re-canalization of infra-inguinal arterial occlusive disease
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde access for re-canalization of infra-inguinal arterial occlusive diseaseProcedure or surgery
after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted
| Study group | Role | What they receive |
|---|---|---|
| patients with infrainguinal arterial occlusive disease after failed antegrade approach | Other | Not described Receives: Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of retrograde approach as regard occurrence of procedure specific complications
safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
Measured: within one year of follow up
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success.
successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site.
technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
Measured: within one year of follow up
Secondary outcomes (2)
clinical success of the procedure
immediate clinical success is defined as regain of distal pulses, revascularization warmness and edema, and/or disappearance of rest pain.
Measured: within one year of follow up
One year limb salvage rate of the procedure
limb salvage is defined as healing of existing wounds with no amputation proximal to metatarsus.
Measured: within one year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdelmagied Ragb Fouda, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974905
- Sponsor's protocol ID
- Soh-Med-21-07-22
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.
PubMed 31834669Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.
PubMed 25241321Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.
PubMed 24650744
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Approach for Management of Infrainguinal Arterial Occlusive Disease After Failed Antegrade Approach in Critical Limb Ischemia Patients; Feasibility, Safety, and Procedure Related Outcomes.
- ClinicalTrials.gov ID
- NCT04974905
- Acronym / sponsor ID
- Soh-Med-21-07-22
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 23 Jul 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.
The spectrum of lower extremity peripheral arterial disease (PAD) ranges from exhibiting no symptoms to limb threatening gangrene. The number of patients living with it is rising steadily owing to increased life expectancy, obesity, diabetes, and tobacco consumption.
Critical limb ischemia (CLI) is the terminal and the most serious stage of PAD in which blood flow to the lower extremity does not meet metabolic demands of the tissues at rest. The diagnosis is mainly clinical and patients are presented with rest pain, minimal tissue loss or frank gangrene.
Revascularization strategies include endovascular procedures and surgical bypass.Endovascular therapy has evolved as an attractive, minimally invasive method of revascularization especially in the more frequently encountered patients with medical and anatomical contraindications to surgical revascularization.
Antegrade approach is the standard approach in infrainguinal arterial occlusive disease,however, failure occurs in about 20% of infrainguinal attempts.Retrograde approach is used as a backup technique in failed cases.
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 infrainguinal arterial occlusive disease after failed antegrade approach | Other | Procedure: retrograde access for re-canalization of infra-inguinal arterial occlusive disease |
Who may qualify
- Ages
- 35 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with;
- CLI consistent with Rutherford categories (4-5).
- Infrainguinal arterial occlusive disease with a patent distal part of at least one tibial vessel runoff to the foot.
Key exclusion criteria (4 listed)
- Non-salvageable limbs.
- Life threatening infections requiring major amputation.
- Ulcers at the area of intended puncture.
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 |
|---|---|---|
| retrograde access for re-canalization of infra-inguinal arterial occlusive diseaseafter failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted | Procedure or surgery | patients with infrainguinal arterial occlusive disease after failed antegrade approach |
Primary outcome
safety of retrograde approach as regard occurrence of procedure specific complications
Time frame: within one year of follow up
safety of retrograde approach after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease, in the light of complications which are classified into major or minor according to the reporting standards of society of vascular surgery.this complications will be looked for and data will be collected
feasibility of retrograde approach as regard successful retrograde puncture and technical success after failed antegrade approach for recanalization of infrainguinal arterial occlusive disease.
Time frame: within one year of follow up
it means that this approach can be used successfuly in clinical practice and this will be assessd by measuring successful retrograde puncture and technical success. successful retrograde puncture means successful performance of retrograde puncture at any of the retrograde distal puncture sites with intraluminal placement of the retrograde guidewire confirmed by contrast angiography without causing procedure specific complications namely local dissection, rupture, or an arteriovenous fistula at puncture site. technical success is defined as successful puncture followed by successful crossing of the occlusion and regain of inline flow to the foot with less than 30%residual stenosis after treatment.
2 secondary outcomes
clinical success of the procedure
Time frame: within one year of follow up
One year limb salvage rate of the procedure
Time frame: within one year of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 31834669Mustapha JA, Saab F, McGoff TN, Adams G, Mullins JR, Al-Dadah A, Jaff MR, Goodney PP, Khawaja F, Diaz-Sandoval LJ. Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME). Catheter Cardiovasc Interv. 2020 Feb 15;95(3):447-454. doi: 10.1002/ccd.28639. Epub 2019 Dec 13.
- Background: PubMed 25241321Hendricks NJ, Sabri SS. Subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) and rertograde access for critical limb ischemia. Tech Vasc Interv Radiol. 2014 Sep;17(3):203-10. doi: 10.1053/j.tvir.2014.08.009. Epub 2014 Sep 4.
- Background: PubMed 24650744Bazan HA, Le L, Donovan M, Sidhom T, Smith TA, Sternbergh WC 3rd. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014 Aug;60(2):375-81. doi: 10.1016/j.jvs.2014.02.038. Epub 2014 Mar 18.
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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.
Hussein K Hussein, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing retrograde access for re-canalization of infra-inguinal arterial occlusive disease in people with Critical Limb Ischemia, run by Sohag University.
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 3 inclusion and 4 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mostafa A Foda, Msc (01012514518, m_foda_revolution2020@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of retrograde approach as regard occurrence of procedure specific complications (time frame: within one year of follow up). 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 NCT04974905, which also lists 3 linked publications.
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 23 Jul 2021.