Unrecognized ConditionNCT03477071
A 15-year Single Center Experience of Endovascular Treatment of Transplant Renal Artery Stenosis
An observational study of Unrecognized Condition, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft. Endovascular treatment is first-line treatment. The main objective of this study is to identify the predictive factors of failure of peri-anastomotic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Angioplasty for Transplant Renal Artery Stenosis (TRAS)
- Type of treatment
- Surgery or procedure
- How many people
- 1,323 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017.
Who may be able to join
- All patients who had a renal transplant from brain-dead donors or from living donors
- All patients who had a Transplant Renal Artery Stenosis
Who cannot join
- None
About this study
Official title: A 15-year Single Center Experience of Endovascular Treatment of Transplant Renal Artery Stenosis: Evaluation of Post-operative Outcomes
Stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft. Endovascular treatment is first-line treatment. The main objective of this study is to identify the predictive factors of failure of peri-anastomotic.
Read the detailed description
The aim of this study was to evaluate the post-operative outcomes following endovascular treatment of TRAS (Transplant Renal Artery Stenosis).
This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017. The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure.
- Conditions
- Unrecognized Condition
- Being tested
- Angioplasty for Transplant Renal Artery Stenosis (TRAS)
- Keywords
- Transplant renal artery stenosis, Endovascular repair, Post-operative outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty for Transplant Renal Artery Stenosis (TRAS)Procedure or surgery
Also called Endovascular treatment
The angioplasty is an endovascular treatment for artery stenosis, which could be associated with stenting or not.
What is being measured
The primary outcome is the main question the study is designed to answer.
The technical success rate of endovascular treatment
The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure
Measured: 30 days
Secondary outcomes (2)
Morbidity rate
Morbidity rate is defined as the development of post-operative complications. Minor and major complications are recorded, corresponding to Clavien Dindo classification
Measured: 30 days
Mortality rate
All death are recorded to identify the mortality rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2010
- Primary completion1 Jan 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477071
- Sponsor's protocol ID
- URO-BASE03
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Submission at several congress: WCE2017, AFU2017 Publication at the Journal of Urology in March 2018
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 15-year Single Center Experience of Endovascular Treatment of Transplant Renal Artery Stenosis: Evaluation of Post-operative Outcomes
- ClinicalTrials.gov ID
- NCT03477071
- Acronym / sponsor ID
- URO-BASE03
- Conditions
- Unrecognized Condition
- Keywords
- Transplant renal artery stenosis, Endovascular repair, Post-operative outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,323 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft. Endovascular treatment is first-line treatment. The main objective of this study is to identify the predictive factors of failure of peri-anastomotic.
Detailed description
The aim of this study was to evaluate the post-operative outcomes following endovascular treatment of TRAS (Transplant Renal Artery Stenosis).
This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017. The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017.
Key inclusion criteria (2 listed)
- All patients who had a renal transplant from brain-dead donors or from living donors
- All patients who had a Transplant Renal Artery Stenosis
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty for Transplant Renal Artery Stenosis (TRAS)Also: Endovascular treatmentThe angioplasty is an endovascular treatment for artery stenosis, which could be associated with stenting or not. | Procedure or surgery | – |
Primary outcome
The technical success rate of endovascular treatment
Time frame: 30 days
The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure
2 secondary outcomes
Morbidity rate
Time frame: 30 days
Mortality rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No. Submission at several congress: WCE2017, AFU2017 Publication at the Journal of Urology in March 2018
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Unrecognized Condition, run by Centre Hospitalier Universitaire de Nice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The technical success rate of endovascular treatment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.