Evaluation of Post-Angioplasty Outcomes

Peripheral Arterial Disease Clinical Trial

Official title:

Evaluation of Post-Angioplasty Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018949
• Other study ID #: 1.0
• Status: Recruiting
• Start date: January 17, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Singapore General Hospital
• Contact: Charyl Yap
• Phone: 6576 7986
• Email: Charyl.yap.j.q[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Minors under age of 21

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Lower limb angioplasty
Patients who have undergone LL angioplasty are enrolled in study for a medical records review.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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