Road-mapping versus ultrasound guidance for retrograde arterial puncture during angioplasty
Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07427108 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sohag
- Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Yohana F Fayez, MBBCh
- Email: yohana_farouz_post@med.sohag.edu.eg
- Phone: +201288374728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.