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Clinical Trials/NCT05018949
NCT05018949
Unknown
Not Applicable

Evaluation of Post-Angioplasty Outcomes

Singapore General Hospital1 site in 1 country1,000 target enrollmentJanuary 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Limb Ischemia
Sponsor
Singapore General Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Amputation Free Survival
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 17, 2019
End Date
December 31, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Minors under age of 21

Outcomes

Primary Outcomes

Amputation Free Survival

Time Frame: 12 months post-op

Freedom from major limb amputation

Freedom from target lesion revascularization

Time Frame: 12 months post-op

Freedom from any interventions to the index treated lesion

Primary Patency

Time Frame: 12 months

Patency of the treated lesion at index procedure

Wound healing rates

Time Frame: 12 months

Healing of index wounds and whether there is any recurrence

Study Sites (1)

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