Sponsor study identifier
observational
1,000
1 country
1
Study Start
January 17, 2019
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2019
Actual (reported)August 22, 2021
Actual (reported)August 24, 2021
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Patients who have undergone LL angioplasty are enrolled in study for a medical records review.
Patients who have undergone LL angioplasty are enrolled in study for a medical records review.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients that have successfully undergone lower limb angioplasty procedures
Singapore General Hospital
Singapore, 169856, Singapore
Tang Tjun Yip
Singapore General Hospital
First Submitted
August 22, 2021
First Posted
August 24, 2021
Study Start
January 17, 2019
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 24, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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