Renal Angioplasty on Atherosclerotic StenosisPARASNCT03686358
Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
An observational study of Renal Angioplasty on Atherosclerotic Stenosis, run by Rennes University Hospital at 1 site in France.
Trial summary
The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Angioplasty on Atherosclerotic Stenosis
- What is being tested?
- Renal artery angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2017to 12 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having undergone renal arterial angioplasty on atherosclerotic stenosis between 01/01/2010 and 12/31/2013 at Rennes University Hospital
Who may be able to join
- OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis
- Resistant arterial hypertension under treatment including a diuretic
- Acute renal failure or ischemic renal failure quickly progressive
- Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI
Who cannot join
- Renal transplant patients
- Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery
- Restenosis on stent, angioplasty of accessory renal artery
- Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty
- Patients objecting to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.
These studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.
Read the detailed description
Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.
There is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.
- Being tested
- Renal artery angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal artery angioplastyProcedure or surgery
Patients meeting the inclusion criteria were selected from the medical records of renal angioplasty performed at the Rennes University Hospital between 01/01/2010 and 12/31/2013. Each selected patient will receive a notice by mail of information. In the absence of opposition from them within a two weeks, the processing of their data will begin :
- Evaluation of the results at 3 years of renal angioplasty on atherosclerotic stenosis performed at Rennes University Hospital
- Evaluation of indications of renal angioplasty on stenosis atherosclerosis performed after 2009 at Rennes University Hospital
- Identification of prognostic factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint at 3 years
Composite endpoint at 3 years :
- Cardiovascular or renal mortality,
- Initiation of a renal replacement therapy or estimated glomerular filtration rate decrease of more than 50%, Cardiovascular morbidity: hospitalization for congestive heart failure, myocardial infarction, myocardium, stroke.
Measured: The inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start29 May 2017
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Angioplasty on Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry FROUGET, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686358
- Sponsor's protocol ID
- 35RC17_3069
- Acronym
- PARAS
- Status last verified
- Sep 2018
- First submitted
- 24 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
- ClinicalTrials.gov ID
- NCT03686358
- Acronym / sponsor ID
- PARAS / 35RC17_3069
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 26 Sep 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.
The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.
These studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.
Detailed description
Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.
There is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having undergone renal arterial angioplasty on atherosclerotic stenosis between 01/01/2010 and 12/31/2013 at Rennes University Hospital
Key inclusion criteria (4 listed)
- OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis
- Resistant arterial hypertension under treatment including a diuretic
- Acute renal failure or ischemic renal failure quickly progressive
- Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI
Key exclusion criteria (5 listed)
- Renal transplant patients
- Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery
- Restenosis on stent, angioplasty of accessory renal artery
- Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty
- Patients objecting to participate to the study
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 |
|---|---|---|
| Renal artery angioplastyPatients meeting the inclusion criteria were selected from the medical records of renal angioplasty performed at the Rennes University Hospital between 01/01/2010 and 12/31/2013. Each selected patient will receive a notice by mail of information. In the absence of opposition from them within a two weeks, the processing of their data will begin : * Evaluation of the results at 3 years of renal angioplasty on atherosclerotic stenosis performed at Rennes University Hospital * Evaluation of indications of renal angioplasty on stenosis atherosclerosis performed after 2009 at Rennes University Hospital * Identification of prognostic factors | Procedure or surgery | – |
Primary outcome
Composite endpoint at 3 years
Time frame: The inclusion day
Composite endpoint at 3 years : * Cardiovascular or renal mortality, * Initiation of a renal replacement therapy or estimated glomerular filtration rate decrease of more than 50%, Cardiovascular morbidity: hospitalization for congestive heart failure, myocardial infarction, myocardium, stroke.
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 Sep 2018.
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.
Thierry FROUGET principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Angioplasty on Atherosclerotic Stenosis, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 5 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Composite endpoint at 3 years (time frame: The inclusion day). 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 Sep 2018.