Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559891
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
THRIVE- THerapeutic IntravasculaR Ultrasound TIVUS REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pivotal Prospective Multicenter 21 Randomized Double Blind Controlled Study Comparing the THerapeutic IntravasculaR Ultrasound TIVUS REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension The THRIVE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THRIVE
Brief Summary:
The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in
1 subjects with hypertension HTN receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDNSham procedure and during 2 months after procedure
2 subjects with controlled hypertension receiving up to 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDNSham procedure and 2 months after the procedure
1 subjects with hypertension HTN receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDNSham procedure and during 2 months after procedure
2 subjects with controlled hypertension receiving up to 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDNSham procedure and 2 months after the procedure
Detailed Description:
THRIVE is an international multicenter randomized double blind sham-controlled study designed to demonstrate the adjunctive effectiveness and safety of the TIVUS System in hypertensive subjects while subjects are maintained off-antihypertensive medications for a 4-week wash-out period before RDNSham procedure and 2 months after procedure At two months after procedure subjects with uncontrolled hypertension are put back on antihypertensive medication according to a medication escalation protocol Unblinding will be performed at 6 months Uncontrolled sham subjects can cross-over to RDN procedure at 6-months The sham procedure will be minimally invasive to reduce risk to subjects All subjects treated with TIVUS will be followed for a maximum of 36 months post procedure
Study Oversight
Has Oversight DMC:
None
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?:
None