Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy

Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02345603

Acronym

PRASDEN

Enrollment

Registered

2015-01-26

Start date

2014-12-31

Completion date

2020-12-31

Last updated

2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Detailed 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.

Interventions

PROCEDURECryo-therapy

Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* planned prophylactic surgery for abdominal aortic aneurysm

Exclusion criteria

* hypotension, * inability to understand study protocol

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure levels	2 months	24 hour mean ambulatory blood pressure levels before and 2 months after surgery

Secondary

Measure	Time frame	Description
Levels of epinephrine and nor-epinephrine in urine	before and 2 months after surgery	Collection of urine for analyses of stress hormones

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026