Evaluation of Post-Angioplasty Outcomes
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
Investigators
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