Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-02-20 @ 12:55 PM
Study NCT ID:
NCT00538759
Status:
TERMINATED
Last Update Posted:
2019-10-01
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis
Sponsor:
Minneapolis Heart Institute Foundation
Organization:
Study Overview
Official Title:
RADiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding shortfall
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADAR
Brief 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.
Patients will be followed for a period of two (2) years. Echocardiographic and clinical endpoint data will be collected and analyzed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: