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A Prospective Danish National Registry of PTRA in Patients With Renovascular Hypertension

NCT ID: NCT02770066

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2035-01-31

Brief Summary

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A prospective Danish national registry of percutaneous transluminal renal angioplasty (PTRA) in high-risk patients with renal artery stenosis selected on the basis of common national criteria, and with a common follow-up protocol for all three Danish centres offering PTRA

Detailed Description

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Conditions

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Renal Artery Obstruction Hypertension, Renovascular Cardiovascular Diseases Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous transluminal renal angioplasty

Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia)

Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician

* Antiplatelet therapy (usually standard)
* Cholesterol-lowering drugs (usually standard)
* Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated)
* Smoking cessation, diet and physical activity (usually standard)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All of the following:

1. At least one of the above eligibility criteria
2. Duplex doppler ultrasonography or renography investigations consistent with hemodynamically significant renal artery stenosis
3. CT angiography or renal arteriography with angiographic renal artery stenosis of ≥ 70 % reduction of the luminal diameter in at least one projection

Exclusion Criteria

1. If angiography/arteriography, ultrasonography or renography is consistent with bilateral significant renal artery stenosis and only one side is treated with PTRA
2. PTRA of a renal artery supplying a kidney which pre-PTRA handles ≤ 10% of the total kidney function (with no blockage of the renin-angiotensin system) and has a kidney size \< 7 cm (length)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Mark Reinhard

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Glostrup University Hospital/ Rigshospitalet

Glostrup Municipality, , Denmark

Site Status RECRUITING

Holbaek Hospital

Holbæk, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense C, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mark Reinhard, PhD

Role: CONTACT

Phone: +45 7845 2455

Email: [email protected]

Kent L Christensen, MD, DMSc

Role: CONTACT

Phone: +45 7845 2455

Email: [email protected]

Facility Contacts

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Niels Henrik Buus, MD, DMSc

Role: primary

Mark Reinhard, MD, PhD

Role: primary

Kent L Christensen, MD, DMSc

Role: backup

Ulrik B Andersen, MD

Role: primary

Jørgen Jeppesen, MD, DMSc

Role: backup

Michael H Olsen, MD, DMSc

Role: primary

Karoline Schousboe, MD, PhD

Role: primary

Ib Abildgaard, MD, DMSc

Role: backup

References

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Reinhard M, Schousboe K, Andersen UB, Buus NH, Rantanen JM, Bech JN, Mafi HM, Langfeldt S, Bharadwaz A, Horlyck A, Jensen MK, Jeppesen J, Olsen MH, Jacobsen IA, Bibby BM, Christensen KL. Renal Artery Stenting in Consecutive High-Risk Patients With Atherosclerotic Renovascular Disease: A Prospective 2-Center Cohort Study. J Am Heart Assoc. 2022 Apr 5;11(7):e024421. doi: 10.1161/JAHA.121.024421. Epub 2022 Mar 24.

Reference Type DERIVED
PMID: 35322677 (View on PubMed)

Other Identifiers

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DAN-PTRA

Identifier Type: -

Identifier Source: org_study_id