Peripheral Arterial DiseaseNCT07427108
Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety
A study testing Road-map guided versus US guided retrograde access in people with Peripheral Arterial Disease and Vascular Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to compare the technical feasibility and safety of road mapping-guided versus ultrasound-guided retrograde arterial puncture in patients with (CLTI) as measured by: Puncture success rate Access-related complication rate (e.g., hematoma, vessel dissection, perforation) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Vascular Diseases
- What is being tested?
- Road-map guided versus US guided retrograde access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults : Both male and female participants.
- Diagnosed with critical limp threatening ischemia (CLTI):
- significant occlusions in the femoropopliteal
- o Rutherford Class 5: Non-healing wounds or ulcers
- Failed or unable to achieve antegrade access:
- Patients requiring retrograde puncture for the procedure.
- Planned intervention with retrograde access: Candidates for endovascular interventions, including angioplasty, stent deployment
Who cannot join
- Active infection at the puncture site: Any localized infection, particularly over the ankle region , will be an exclusion.
- Severe calcification or anatomical abnormalities: Patients with excessive arterial calcification or significant anatomical distortion preventing safe retrograde puncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag, 82511
Yohana Farouz Fayez, MBBCh, +201288374728, yohana_farouz_post@med.sohag.edu.eg
About this study
The study aims to compare the technical feasibility and safety of road mapping-guided versus ultrasound-guided retrograde arterial puncture in patients with (CLTI) as measured by:
- Puncture success rate
- Access-related complication rate (e.g., hematoma, vessel dissection, perforation)
- Conditions
- Peripheral Arterial Disease, Vascular Diseases
- Being tested
- Road-map guided versus US guided retrograde access
- Medical subject headings
- Peripheral Arterial Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Road-map guided versus US guided retrograde accessProcedure or surgery
Road-map guided versus US guided retrograde access
| Study group | Role | What they receive |
|---|---|---|
| Road Mapping Guided Puncture | Experimental | Not described Receives: Procedure: Road-map guided versus US guided retrograde access |
| Ultrasound Guided Puncture | Active comparator | Not described Receives: Procedure: Road-map guided versus US guided retrograde access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Measured: 12 months
Complication rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohana Farouz Fayez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427108
- Sponsor's protocol ID
- Soh-Med-26-1-1MS
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety
- ClinicalTrials.gov ID
- NCT07427108
- Acronym / sponsor ID
- Soh-Med-26-1-1MS
- Conditions
- Peripheral Arterial Disease, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Feb 2026 (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 study aims to compare the technical feasibility and safety of road mapping-guided versus ultrasound-guided retrograde arterial puncture in patients with (CLTI) as measured by:
- Puncture success rate
- Access-related complication rate (e.g., hematoma, vessel dissection, perforation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Road Mapping Guided Puncture | Experimental | Procedure: Road-map guided versus US guided retrograde access |
| Ultrasound Guided Puncture | Active comparator | Procedure: Road-map guided versus US guided retrograde access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults : Both male and female participants.
- Diagnosed with critical limp threatening ischemia (CLTI):
- significant occlusions in the femoropopliteal
- o Rutherford Class 5: Non-healing wounds or ulcers
- Failed or unable to achieve antegrade access:
Key exclusion criteria (2 listed)
- Active infection at the puncture site: Any localized infection, particularly over the ankle region , will be an exclusion.
- Severe calcification or anatomical abnormalities: Patients with excessive arterial calcification or significant anatomical distortion preventing safe retrograde 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 |
|---|---|---|
| Road-map guided versus US guided retrograde accessRoad-map guided versus US guided retrograde access | Procedure or surgery | Road Mapping Guided Puncture, Ultrasound Guided Puncture |
Primary outcome
Success rate
Time frame: 12 months
Complication rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Road-map guided versus US guided retrograde access in people with Peripheral Arterial Disease and Vascular Diseases, run by Sohag 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yohana F Fayez, MBBCh (+201288374728, yohana_farouz_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 12 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?
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 Feb 2026.