Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332911
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
ShockwavePeripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Sponsor:
Rede Optimus Hospitalar SA
Organization:
Rede Optimus Hospitalar SA
Study Overview
Official Title:
International Multi-center Study to Confirm the Safety and Performance of the ShockwavePeripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
TEVAR
Brief Summary:
Shockwave TEVAR is a nonrandomized prospective international multi-center PMCF obervational study
The aim of this study is to evaluate the outcomes of the Shockwave Peripheral Intravascular Lithotripsy Balloon Shockwave Medical Inc in the routine treatment of hostile iliac accesses during TEVAR and FBEVAR
The aim of this study is to evaluate the outcomes of the Shockwave Peripheral Intravascular Lithotripsy Balloon Shockwave Medical Inc in the routine treatment of hostile iliac accesses during TEVAR and FBEVAR
Detailed Description:
Standardized forms will collect data on the performed procedure underlying pathology cardiovascular risks and information on preoperative examinations Physiological parameters routinely measured prior during and after any surgical intervention will be recorded as well A 1 month 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure
In addition this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic throaco-abdominal or abdominal aortic repair
In addition this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic throaco-abdominal or abdominal aortic repair
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None