Ignite Creation Date:
2025-12-18 @ 9:55 AM
Ignite Modification Date:
2025-12-23 @ 9:12 PM
Study NCT ID:
NCT06829914
Status:
None
Last Update Posted:
2025-10-08 00:00:00
First Post:
2024-10-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Sponsor:
None
Organization:
Study Overview
Official Title:
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Status:
None
Status Verified Date:
2025-10
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:
Shockify
Brief Summary:
This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwave™ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either Shockwave™ IVL + DCB (drug-coated balloon) procedure or a standard surgical endarterectomy. The study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic CFA stenosis receiving Shockwave™ IVL with DCB versus surgical endarterectomy.
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?: