Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
STRIKE
Brief Summary:
Vascular calcification is prevalent in patients with Peripheral artery disease PAD especially those with combined diabetes or chronic kidney disease Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity Calcification may also affect the outcome of endovascular therapy leading to unsatisfactory vasodilation and increase the risk of vascular complications including restenosis and dissection perforation and distal embolization At present according to the degree of calcification and the scope of the lesion it can be divided into light medium and severe three grades Neither high pressure balloon nor atherectomy can significantly improve severe calcification The efficacy of these treatments has also not been tested in multicenter real-world studies Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure reducing the damage of vascular intima and thus reducing postoperative complications The currently published Disrupt PAD III Trial NCT02923193 in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial RCT The residual stenosis rate was lower 664 vs 519 p 002 the incidence of fluid limiting intersections was low 14 vs 68 p 003 the rate of post-expansion and recovery support was also low 52 vs 170 p 0001 46 vs 183 p 0001 The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification Due to its short market-time it is currently only used in large vascular surgery centers On this basis investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification
Detailed Description:
None
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