Trans-pedal Access for Endovascular Revascularization in Complex Infra-popliteal Lesions in Critically Ischemic Limb

NCT05436405 | Completed

• 1 other identifier: mansouravascular
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Background: critical limb ischemia is one of the most challenging cases we face nowadays with high risk for amputation, retrograde trans-pedal angioplasty offers an alternative technique after failure of traditional ante-grade angioplasty. Patients and Methods: 96 patients underwent trans-pedal or trans-tibial retrograde angioplasty after failure of the traditional ante-grade angioplasty with the aid of US, 21-gauge needle and 0.018 wire through sheath-less approach as a last chance for revascularization

Conditions

Critical Lower Limb Ischemia

Keywords

transpedal access; retrogradeangioplasty; critical limb ischemia

Outcome Measures

Primary Outcomes (3)

• primary patency

  patency of the vessels after intervention

  one year

• amputation free survival rates

  limb salvage after precedure

  one year

• 30 days' mortality and morbidity.

  major adverse effects related to procedure

  30 days

Study Arms (1)

transpedal access

EXPERIMENTAL

Trans-pedal Access for Endovascular Revascularization in patients with failed antegrade access forComplex Infra-popliteal Lesions in Critically Ischemic Limb

Procedure: Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb

Interventions

Trans-pedal access for endovascular revascularization in complex infra-popliteal lesions in critically ischemic limb PROCEDURE

Briefly, conventional femoral access will be conducted in the traditional manner and involve the sheath while the catheter was introduced close to the proximal degree of lesion. Access to a pedal vessel: Using a 21-guage needle or by utilizing a micro puncture access set. Such vessel is recognized using the US probe. such approach performed in 54 patients.a fluoroscopy might enable a good possibility for efficient access. In addition, it was suggested to utilize micro-puncture needle supposed to have echogenic pattern as the tip of regular needle is very hard to visualize utilizing the duplex US probe. Also, use of straight fluoroscopy or road mapping may offer a better chance for successful access, this method is done in 31 cases . Another method is open method (cut down) on tibial vessels, this method is done in 11 cases.

transpedal access

Eligibility Criteria

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

You may qualify if:

• all patients aged from (18-80) years, males and female
• patients with 1ry lesion (without previous trial of angioplasty or bypass)
• ry lesion (after previous trial of angioplasty or bypass),
• the patients with fountain classification (stage IIB, stage III, stage IV)
• patients with Rutherford classification (grade I "category 3", grade II, Category 4", grade III, Category 4\&category 5.

You may not qualify if:

• patients with untreated osteomyelitis,
• patients with mixed lesions with other comorbidities (CVI \& Lymphoedema),
• patients with vasculitis or Buerger's dis.
• Also, who can't give consent (mentally retarded patients) or those with behavioral disorders .

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35615, Egypt

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 29, 2022
• Study Start: March 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)