Evaluation of Post-Angioplasty Outcomes

NCT05018949 | Unknown

• 1 other identifier: 1.0
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Limb Ischemia; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• Amputation Free Survival

  Freedom from major limb amputation

  12 months post-op

• Freedom from target lesion revascularization

  Freedom from any interventions to the index treated lesion

  12 months post-op

• Primary Patency

  Patency of the treated lesion at index procedure

  12 months

• Wound healing rates

  Healing of index wounds and whether there is any recurrence

  12 months

Study Arms (1)

Patients who have undergone LL angioplasty

Patients who have undergone LL angioplasty are enrolled in study for a medical records review.

Procedure: Lower limb angioplasty

Interventions

Lower limb angioplasty PROCEDURE

Patients who have undergone LL angioplasty are enrolled in study for a medical records review.

Patients who have undergone LL angioplasty

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients that have successfully undergone lower limb angioplasty procedures

You may qualify if:

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

You may not qualify if:

• Minors under age of 21

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Tang Tjun Yip

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

6576 7986; Charyl.yap.j.q@sgh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 24, 2021
• Study Start: January 17, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)