Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 1:31 PM
Study NCT ID:
NCT06713850
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
Sponsor:
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries
Status:
RECRUITING
Status Verified Date:
2024-11
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:
SHIELD
Brief Summary:
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.
Detailed Description:
Vascular calcification is prevalent in patients with peripheral artery disease (PAD), especially those with comorbid diabetes or chronic kidney disease. Severe calcification portends a poor prognosis and is independently associated with an increased risk of cardiovascular mortality and morbidity. Calcification may also compromise the efficacy of endoluminal therapy, leading to suboptimal vasodilatation and an increased risk of vascular complications, including restenosis, as well as entrapment, perforation, and distal embolization. The current grading of vascular calcification is based on the PACSS score, which can be categorized as mild, moderate, or severe depending on the degree of calcification and the extent of the lesion. Neither high-pressure balloon angioplasty nor plaque resection (atherectomy) significantly improves severely calcified lesions. The efficacy of these treatment modalities has also not been validated in multicenter real-world studies. Shockwave balloons have been widely used in the clinical endoluminal treatment of severely calcified lesions due to their ability to significantly disrupt calcified structures while reducing damage to the vascular intima, thereby reducing postoperative complications. The current published study Disrupt PAD III Trial (NCT02923193) of shockwave balloon treatment of calcified lesions demonstrated a lower residual stenosis rate with shockwave balloon versus balloon dilatation alone in a randomized controlled trial (RCT) (66.4% vs. 51.9%; p = 0.02), limiting the number of patients who could be treated with shockwave balloon. p = 0.02), a lower incidence of flow-limiting entrapment (1.4% vs. 6.8%; p = 0.03), and a lower rate of posterior dilation and remedial stenting (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p \< 0.001). Shockwave balloons have been approved by the Chinese Food and Drug Administration for endoluminal treatment of severe calcification of the femoropopliteal artery, and are currently used only in larger vascular surgery centers because of their short time on the market. On this basis, we asked whether we could set up a real-world study of shockwave balloons for the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloons in the treatment of moderate-to-severe calcified lesions.
Study Oversight
Has Oversight DMC:
True
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?: