An observational study in Critical Limb Ischemia and Peripheral Arterial Disease, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Singapore General Hospital · Observational
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
348 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 123 across 99 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Singapore General Hospital is the lead sponsor of 270 studies on the registry; 58 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients that have successfully undergone lower limb angioplasty procedures
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who have undergone LL angioplasty are enrolled in study for a medical records review.
Procedure: Lower limb angioplasty
Patients who have undergone LL angioplasty are enrolled in study for a medical records review.
Amputation Free Survival
Freedom from major limb amputation
Time frame: 12 months post-op
Freedom from target lesion revascularization
Freedom from any interventions to the index treated lesion
Time frame: 12 months post-op
Primary Patency
Patency of the treated lesion at index procedure
Time frame: 12 months
Wound healing rates
Healing of index wounds and whether there is any recurrence
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2023, 59 months after the start.
Of 45 non-industry observational studies under Chronic Limb-Threatening Ischemia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 60. This study's planned 59 months is above that.
Counting every sponsor, half of 50 studies reached it within 34 months; a quarter within 22 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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