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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| three vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries |
|
| two vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of two infrapopliteal arteries |
|
| single vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of only one infrapopliteal artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon angioplasty | Procedure | endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area |
| Measure | Description | Time Frame |
|---|---|---|
| limb salvage rate | percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty | 6 months ( with optional follow up at 12 months ) |
| limb salvage rate | percentage of patients who avoid major amputation during the period of follow up following angioplasty procedure | 6 months ( with optional follow up at 12 months ) |
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Inclusion Criteria: 1. patients aged 40 years or older 2. patients with Rutherford category "4" and "5" 3. patients with angiographic evidence of infrapopliteal vessel occlusive disease -
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Abdelrahman hafez, Master's student | Contact | +0201060150246 | mahmoud.abdelrahmaan@med.sohag.edu.eg | |
| Mahmoud El-saedy, MB BCh ( candidate ) | Contact | +0201120908609 | elsaedymahmoud13@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine of Sohag | Recruiting | Sohag | Sohag Governorate | 82511 | Egypt |
not applicable data will be used internally for academic purpose only
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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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
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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
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |