Comparing observation and stenting for kidney transplant artery narrowing
Transplant Renal Artery Stenosis: Observation Versus Stenting - a Feasibility Study
This study is trying to see if watching closely or using a stent is better for treating kidney transplant patients with narrowed arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College Healthcare NHS Trust Academic / other |
| Locations | 1 site (London, England) |
| Trial ID | NCT05046496 on ClinicalTrials.gov |
What this trial studies
This study investigates transplant renal artery stenosis (TRAS), a condition characterized by the narrowing of the main blood vessel supplying a kidney transplant. It aims to explore the various factors contributing to TRAS, including surgical, cardiovascular, and immunological influences. The study will assess the optimal diagnostic and management strategies for TRAS, particularly focusing on the use of intra-arterial digital subtraction angiography (IADSA) as a potential intervention. By understanding the underlying processes and treatment options, the study seeks to improve outcomes for kidney transplant recipients affected by this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are renal transplant recipients diagnosed with TRAS who are 18 years or older and can provide informed consent.
Not a fit: Patients with severe TRAS symptoms or those with contraindications to angiography are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for kidney transplant recipients with TRAS, potentially enhancing transplant longevity and patient quality of life.
How similar studies have performed: While there is limited consensus on the treatment of TRAS, similar studies in heart transplantation have shown that addressing vascular complications can significantly impact transplant outcomes, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 1. Renal transplant recipient with a diagnosis of TRAS by radiological imaging, and an MDT decision to proceed with diagnostic IADSA. 2. Aged 18 years and over 3. Able to give informed consent Exclusion Criteria: - 1. Estimated GFR \<10mls/min/1.73m2 or dialysis dependence 2. Contraindication to angiography (e.g. allergy to radiological contrast) 3. Patients with clinical features of severe TRAS (eg. resistant hypertension, pulmonary oedema and/or rapidly deteriorating function). 4. Any condition or co-morbidity which in the investigator's opinion would make the patient ineligible for the trial or unlikely to adhere to trial procedures.
Where this trial is running
London, England
- Imperial College Healthcare NHS Trust — London, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Michelle Willicombe — Imperial College London
- Study coordinator: Paul Martin
- Email: paul.martin9@nhs.net
- Phone: 02033136641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.