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Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy (PRASDEN)

U

University Hospital, Linkoeping

Status and phase

Unknown
Phase 4

Conditions

Hypertension

Treatments

Procedure: Cryo-therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02345603
2014/45-31

Details and patient eligibility

About

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.

Full description

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.

Enrollment

9 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • planned prophylactic surgery for abdominal aortic aneurysm

Exclusion criteria

  • hypotension,
  • inability to understand study protocol

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9 participants in 2 patient groups

Cryo-therapy
Experimental group
Description:
Cryo-therapy of renal arteries
Treatment:
Procedure: Cryo-therapy
Control
No Intervention group
Description:
No intervention in renal arteries

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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