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Renal Artery Fibromuscular DysplasiaDysArtNCT02586870

Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment

A study testing Intravascular Ultrasound in people with Renal Artery Fibromuscular Dysplasia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective multicenter study based on the validation of diagnostic criteria and predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia. This is considered as a rare disease and patients are usually treated in specialized centers involved in a national network. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Artery Fibromuscular Dysplasia
What is being tested?
Intravascular Ultrasound
Type of treatment
Medical device
How many people
41 participants
Where
1 siteFrance
Study dates
Nov 2015to 2 Feb 2020
Phase
Interventional
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

Who may be able to join

  • Adult patients
  • hypertension based on ambulatory BP 24H measurements (12h mean daytime BP ≥135 or 85 mmHg)
  • renal artery stenosis due to multifocal FMD of the main renal artery or accessory artery with a diameter ≥ 5mm (defined using CT scan or duplex ultrasound),
  • if clinical and para-clinical information suggest that the hypertension might be caused by the renal stenosis and will require intravascular revascularization because of:
  • Recent onset of hypertension
  • Resistant hypertension (hypertension treated by 3 hypertensive drugs including one diuretic) based on ambulatory BP measurements (12h mean daytime BP ≥135 or 85 mmHg)
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  • Hypertension for patients with poor compliance to medications or medication side effects.
  • Acute flash pulmonary edema
  • Delayed onset of hypertension with a decrease in kidney size or recent onset of renal failure especially after a renin-angiotensin system blocker

Who cannot join

  • Patients with other causes of secondary hypertension
  • Patients with renal artery stenosis from other causes than FMD higher than 30%
  • Patients with unifocal FMD or intimal FMD
  • Multifocal FMD of an accessory renal artery with a diameter < than 5 mm.
  • Patient with involvement of a collateral artery of the main renal artery
  • Renal artery dissection
Show all 12Show fewer
  • Patients with creatinine clearance (MDRD) lower that 40ml/min/1.73m2.
  • Patients with an aneurysm with a diameter more than twice the diameter of the concerned artery
  • Patients without a social security number
  • Pregnant patients
  • Patients who refuse to participate in the study
  • Patients for whom the invasive measure are not possible

Trial locations and contacts

1 site in 1 country.

France1 site

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354

Other trials in France

About this study

This is a prospective multicenter study based on the validation of diagnostic criteria and predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia. This is considered as a rare disease and patients are usually treated in specialized centers involved in a national network. Marseille is a center specialized in FMD and a member of the network that is very active across the country. In order to rapidly recruit patients the investigators propose a multicenter study. All patients included will benefit from an invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral stenosis the investigators will randomly omit data from one side and consider the data from the contralateral artery for further analysis, to avoid statistical interdependency. Patients who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral but with one non significant stenosis based on duplex ultrasound European recommendations for atherosclerotic renal artery stenosis) will be included in the second part of the study. These patients will in addition benefit from a trans stenotic pressure assessment under vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal artery stenosis will not be included in the analysis to assess predictive criteria for treatment efficacy on hypertension, treatment of these patients will followed the current best clinical practice. These patients will be followed during 6 to 8 month to assess potential complication of the pressure assessment renal artery stenosis, but their data will be included to assess the value of FFR and IVUS to guide the procedure. Patients with unilateral stenosis will be followed up 6 month after angioplasty in order to assess hypertension and to look for potential complications.

Being tested
Intravascular Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravascular UltrasoundDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MAXIMAL VELOCITY

    duplex ultrasound parameters

    Measured: 24 months

  2. ratio between maximal speed in the renal artery and in the aorta

    duplex ultrasound parameters

    Measured: 24 MONTHS

  3. resistance index

    duplex ultrasound parameters

    Measured: 24 MONTHS

  4. systolic ascension time

    duplex ultrasound parameters

    Measured: 24 MONTHS

Secondary outcomes (4)

  1. stenosis length

    MDCT anatomical parameters

    Measured: 24 months

  2. arterial diameter

    MDCT anatomical parameters

    Measured: 24 MONTHS

  3. number of the stenosis

    MDCT anatomical parameters

    Measured: 24MONTHS

  4. Distance Ostium / main stenosis

    MDCT anatomical parameters

    Measured: 24 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion2 Feb 2020
  4. Study completion2 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586870
Sponsor's protocol ID
2015-A01244-45
Other IDs
2015-14
Acronym
DysArt
Status last verified
Aug 2022
First submitted
22 Oct 2015
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Cadour F, Silhol F, Iline N, Giorgi R, Lorthioir A, Amar L, Sapoval M, Rousseau H, Sarlon G, Thony F, Jacquier A. Insights from intravascular pressure measurement of renal artery revascularization in patients with fibromuscular dysplasia: The DYSART study. J Vasc Surg. 2022 Mar;75(3):939-949.e1. doi: 10.1016/j.jvs.2021.09.023. Epub 2021 Sep 30.

    PubMed 34601043

Questions about this trial

What is this clinical trial studying?

A study testing Intravascular Ultrasound in people with Renal Artery Fibromuscular Dysplasia, run by Assistance Publique Hopitaux De Marseille 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 9 inclusion and 12 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 16 Aug 2022. 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?

MAXIMAL VELOCITY (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586870, which also lists 1 linked publication.

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 16 Aug 2022.

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