NCT02345603

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Cryo-therapy	Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2015-01-26
• Last updated: 2019-04-24

Locations

1 site across 1 country: Sweden