Road-mapping versus ultrasound guidance for retrograde arterial puncture during angioplasty
Official title: Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety
Run by Sohag University · NCT07427108 · Data updated 2026-11-12
This trial will test whether using road mapping or ultrasound to guide retrograde arterial puncture works better and is safer for adults with critical limb-threatening ischemia who need retrograde access during angioplasty.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07427108 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with critical limb-threatening ischemia (Rutherford Class 5) who have failed or cannot achieve antegrade access and are planned for retrograde endovascular intervention, without local infection or prohibitive arterial calcification/anatomical distortion, are ideal candidates.
✕Probably not a fit
Patients with active infection at the puncture site, severe arterial calcification or anatomy that prevents safe retrograde puncture, or those who do not require retrograde access are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with critical limb-threatening ischemia who cannot obtain antegrade access and are scheduled for retrograde endovascular intervention will undergo retrograde arterial puncture guided either by road mapping (fluoroscopic roadmap) or by ultrasound. The study will compare technical measures such as puncture success rate and procedure-related access complications (for example hematoma, vessel dissection, or perforation). Procedures are performed at a single center and safety and feasibility outcomes will be recorded for each approach. The goal is to determine which guidance method provides more reliable access with fewer complications in this high-risk patient group.
Why it matters
Potential benefit: If successful, the preferred guidance method could increase the chance of successful retrograde access and reduce access-related complications, potentially improving limb salvage and procedural safety.
How similar studies have gone: Ultrasound guidance and fluoroscopic road mapping are both used in practice and have shown utility, but direct head-to-head comparisons specifically for retrograde puncture in CLTI are limited, so this feasibility/safety comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: -. 1. Adults : Both male and female participants. 2. Diagnosed with critical limp threatening ischemia (CLTI): significant occlusions in the femoropopliteal o Rutherford Class 5: Non-healing wounds or ulcers 3. Failed or unable to achieve antegrade access: Patients requiring retrograde puncture for the procedure. 4. Planned intervention with retrograde access: Candidates for endovascular interventions, including angioplasty, stent deployment Exclusion criteria: • 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.
Where it's running
-
Sohag University Hospital
Sohag, Egypt Recruiting
Study contacts
- Study coordinator: Yohana F Fayez, MBBCh
- Email: yohana_farouz_post@med.sohag.edu.eg
- Phone: +201288374728
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.