Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia

NCT ID: NCT07068789

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2025-09-25

Brief Summary

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This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period

Detailed Description

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Conditions

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Chronic Limb Threatening Ischemia Infrapopliteal Arterial Occlusive Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of two parallel groups based on the revascularization strategy received : single vessel infrapopliteal angioplasty or multiple vessel infrapoplital angioplasty . Each participant will remain in the same intervention group throughout the study period and outcomes will be comapred between the two groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

due to nature of the intervention procedures masking was not feasible the number of infrapopliteal arteries treated is clearly documented in procedural reports and imaging and therefore both participants and treating physicians were aware of the assigned intervention

Study Groups

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three vessel revascularization

patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries

Group Type EXPERIMENTAL

balloon angioplasty

Intervention Type PROCEDURE

endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area

two vessel revascularization

patients in this group will undergo will receive angioplasty of two infrapopliteal arteries

Group Type EXPERIMENTAL

balloon angioplasty

Intervention Type PROCEDURE

endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area

single vessel revascularization

patients in this group will undergo will receive angioplasty of only one infrapopliteal artery

Group Type EXPERIMENTAL

balloon angioplasty

Intervention Type PROCEDURE

endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area

Interventions

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balloon angioplasty

endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

1. patients who refuse to participate in the study
2. patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
3. patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Abdelrahman Hafez

Mahmoud Abdelrahman Hafez

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine of Sohag

Sohag, Sohag Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mahmoud Abdelrahman hafez, Master's student

Role: CONTACT

+0201060150246

Mahmoud El-saedy, MB BCh ( candidate )

Role: CONTACT

+0201120908609

Facility Contacts

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Mahmoud Elsaedy, master student

Role: primary

+0201060150246

Other Identifiers

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Soh-Med-25-6-14MS

Identifier Type: -

Identifier Source: org_study_id

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