NCT00538759

Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

RADiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.

Detailed description

The RADAR trial is a prospective, randomized, double-blind, sham-controlled, two-stage, adaptive clinical trial. Following successful Balloon Aortic Valvuloplasty, patients with severe aortic stenosis will be randomized in a 2:1 fashion to External Beam Radiation Therapy (EBRT) plus standard medical therapy or standard medical therapy along with sham EBRT (placebo). During Stage One, approximately 110 patients will be enrolled in order to have 80 patients randomized and 66 patients with valid 6 month data. The sample size for Stage Two will be calculated at the end of Stage One. At the time of study commencement, the expectation is that the total sample size will be approximately 155 patients with valid 6-month data, and thus 195 will be randomized and up to 250 enrolled. Patients will be followed for a period of two (2) years. Echocardiographic and clinical endpoint data will be collected and analyzed.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	External beam radiation therapy	Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty
OTHER	Sham Control

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-10-03
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

2 sites across 1 country: United States