Road Mapping Guided Puncture Versus Ultrasound Guided Puncture During Retrograde Angioplasty Feasibility and Safety

February 15, 2026 updated by: Yohana Farouz Fayez, Sohag University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Road Mapping Guided Puncture
Procedure: Road-map guided versus US guided retrograde access
Road-map guided versus US guided retrograde access
Active Comparator: Ultrasound Guided Puncture
Procedure: Road-map guided versus US guided retrograde access
Road-map guided versus US guided retrograde access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: 12 months
12 months
Success rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-1-1MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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