Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-31 @ 3:18 PM
Study NCT ID:
NCT01835535
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continued Safety and Performance of the TIVUS System
Sponsor:
Cardiosonic
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:
* TIVUS™ Severe Resistant HTN Cohort
* TIVUS™ Moderate Resistant HTN Cohort
* TIVUS™ Failed RF Therapy Cohort
* TIVUS™ Severe Resistant HTN Cohort
* TIVUS™ Moderate Resistant HTN Cohort
* TIVUS™ Failed RF Therapy Cohort
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: