Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Claudication

Occlusions

Treatment

Shockwave balloons

Clinical Study ID

NCT06713850

the SHIELD study

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18 years (2) Rutherford Classification 2-5 3) Stenosis (>70% stenosisconfirmed by digital subtraction angiography (DSA) imaging) or occlusion of thefemoropopliteal artery, with one healthy patent outflow tract distal to the knee incontinuity with a patent outflow tract below the ankle.

(4) Patients who understand the purpose of the study, participate in the experiment voluntarily, sign the informed consent form and are willing to be followed up.

The guidewire needs to pass through the lesion; 6) Life expectancy >24 months 7)Moderately severe calcified lesions confirmed by imaging data: 8) For patients whoreceive intervention in both lower extremities may be enrolled in order of time ofintracavitary treatment 9) For combined aortoiliac artery lesions that haveundergone endoluminal revascularization to achieve flow recanalization without morethan 50% residual stenosis.

Exclusion

Exclusion Criteria:

Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiacinfarction within 3 months prior to enrollment (2) Patients with known allergy toheparin, aspirin, other antiplatelet drugs, contrast agents, etc.

Patients who have been enrolled in medications that interfere with this clinicaltrial within the last 3 months or who have been treated intraoperatively with otherspecial vascular bed preparation devices, such as plaque volume reduction devices,special balloons, and so on; 4) Pregnant and lactating women 5) Patients who areunable or unwilling to participate in this trial. 6) patients with Berger's disease
patients who have received arterial bypass diversion on the treated side

Study Design

Shockwave balloons

December 01, 2024

November 30, 2028

Study 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.

Connect with a study center

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
China
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.