Pedal Arch Revascularization in Patients With Chronic Limb Threatening Ischemia

NCT05098548 | Unknown

• 1 other identifier: PARIPWCLTI
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Conditions

Critical Ischemia of Foot

Outcome Measures

Primary Outcomes (1)

• Patency of the vessel

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

  From December 2021 to April 2022

Study Arms (1)

patients with Chronic limb threatening ischemia

All patients with Chronic limb threatening ischemia present with one or more of the following: 1. Rest pain (Rutherford category 4) 2. Minor tissue loss (Rutherford category 5) admitted to the department of Vascular surgery for Endovascular Intervention with provided written informed consent.

Procedure: angioplasty

Interventions

angioplasty PROCEDURE

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 .

patients with Chronic limb threatening ischemia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The calculation was done using confidence interval 98 % giving a total sample size 28. According to the equation for sample size for prospective study design, prevalence of chronic limb threatening ischemia was 1.3 % of total population attending the Vascular Surgery Department \[2\]. Raising the sample size will be done up to 35 to compensate for dropout and refusal.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: October 28, 2021
• Study Start: December 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share