Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05098548
Collaborator
(none)
35
12

Study Details

Study Description

Brief Summary

Chronic limb threatening ischemia (CLTI) is a major cause of morbidity and mortality worldwide and is characterized by multilevel disease, often involving the tibiopedal vessels . CLTI is an undesirable clinical consequence of peripheral arterial disease (PAD) . It affected ∼8 million people in the USA and affects 12-20% of American people aged more than 65 years. Within 1 year of diagnosis, 25% of those patients progress to a major amputation and the other 25% die due to co-morbid conditions

Condition or Disease Intervention/Treatment Phase
  • Procedure: angioplasty

Detailed Description

Revascularization is the cornerstone of Chronic limb threatening ischemia (CLTI) treatment for lower limb preservation . Endovascular revascularization is the favored approach in many centers because of its lower morbidity and mortality than open surgery . In a subset of patients with Chronic limb threatening ischemia, particularly in longstanding type 1 diabetic patients, a predominance of disease involving the pedal vessels can exist with relative sparing of the tibial vessels .The pedal arch describes the connection between the anterior and posterior circulation in the foot, this typically runs from the lateral plantar artery into the dorsalis pedis and represents the final arcade of outflow for the lower extremity vasculature . Secondary or "deep" pedal plantar loops connecting the medial and lateral tarsal arteries to the medial and lateral plantar arteries can also exist . A strong understanding of the pedal arch anatomy and its multiple connections is important for the physician performing not only pedal arch interventions, but tibial interventions as well . Familiarity with the arch anatomy increases procedural success rates in tibial intervention, as it gives the operator another collateral pathway to approach the target occlusion in a retrograde fashion . An intact pedal arch has been associated with improved wound healing, as well as a higher patency rate for bypass grafting and percutaneous interventions for inflow disease . An Angio some-directed revascularization strategy, however, has clearly been shown to improve wound healing and limb salvage rates in both surgical and endovascular series . Pedal arch intervention should therefore be considered in patients with advanced tissue loss, with a goal of restoring inline flow to the corresponding angiosomes, this could mean the difference between a major and minor amputation, as the options for these patients are limited and major amputation rates are high .

Study Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Pedal Arch Patency on Outcomes of Endovascular Revascularization Procedures in Patients With Chronic Limb Threatening Ischemia
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
patients with Chronic limb threatening ischemia

All patients with Chronic limb threatening ischemia present with one or more of the following: Rest pain (Rutherford category 4) Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Procedure: angioplasty
using a balloon to stretch open a narrowed or blocked artery. However, most modern angioplasty procedures also involve inserting a short wire-mesh tube, called a stent, into the artery during the procedure. The stent is left in place permanently to allow blood to flow more freely .

Outcome Measures

Primary Outcome Measures

  1. Patency of the vessel [From December 2021 to April 2022]

    Primary patency Which means maintaining vessel patency without restenosis or need for re-intervention .

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

All patients with Chronic limb threatening ischemia present with one or more of the following:

  • Rest pain (Rutherford category 4)

  • Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Exclusion Criteria:
  • Patients presented with proved vasculitis.

  • Patients with Chronic liver disease if there is prolonged PT.

  • Patients with Heart failure if the patient is orthopneic and cannot lay on table for long time).

  • Patients with impaired renal function.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Moustafa Farouk, principle investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05098548
Other Study ID Numbers:
  • PARIPWCLTI
First Posted:
Oct 28, 2021
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022