Evaluation of Post-Angioplasty Outcomes

• Conditions: Critical Limb Ischemia; Peripheral Arterial Disease
• Interventions: Procedure: Lower limb angioplasty

• Registration Number: NCT05018949
• Lead Sponsor: Singapore General Hospital

Brief Summary

There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be conservative or aggressive.

Angioplasty can help restore blood flow and long-term patency of the blood vessels can help prevent major surgeries, such as amputation which affects patient's quality of life. However, some of these patients do not benefit from angioplasty and eventually had to undergo amputation. On the other hand, there are patients that undergo amputation, but may stand to benefit from angioplasty. Hence, it is essential to identify patients that will likely benefit from angioplasty to increase limb salvage rate. Many studies performed have also concluded that before amputations are performed, surgeons should consider angioplasty procedures.

Through a medical record review of patients that have undergone angioplasty to evaluate post-angioplasty outcomes, we hope to identify factors that potentially affects these outcomes. Ultimately with a better understanding of these factors and their impact on angioplasty outcomes, a predictive model or guideline can be developed to identify patients that stands to benefit from angioplasty. Such a model can help clinicians to better counsel patients on the risk and benefits, alternatives and prognosis. Patients can also make a better informed decision regarding their treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-17
• Status Verified: 2021-08
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients admitted into SGH Department of Vascular Surgery, and have successfully undergone angioplasty

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Exclusion Criteria

• Minors under age of 21

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have undergone LL angioplasty	Lower limb angioplasty	Patients who have undergone LL angioplasty are enrolled in study for a medical records review.

Primary Outcome Measures

Name	Time	Method
Amputation Free Survival	12 months post-op	Freedom from major limb amputation
Freedom from target lesion revascularization	12 months post-op	Freedom from any interventions to the index treated lesion
Primary Patency	12 months	Patency of the treated lesion at index procedure
Wound healing rates	12 months	Healing of index wounds and whether there is any recurrence

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore