Clinical trial NCT06713850: Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
Official title: Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease (PAD)
Chronic Limb Threatening Ischemia
Keywords: Peripheral Artery Disease
Chronic Limb Threatening Ischemia
Severe calcification
Lead sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Huashan Hospital
name: Xuanwu Hospital, Beijing
name: The General Hospital of Southern Theater Command
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: RenJi Hospital
name: Chengdu University of Traditional Chinese Medicine
First posted: 2024-12-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with PAD.

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.

Eligibility criteria: Inclusion Criteria:

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1) Age ≥ 18 years (2) Rutherford Classification 2-5 3) Stenosis (\>70% stenosis confirmed by digital subtraction angiography (DSA) imaging) or occlusion of the femoropopliteal artery, with one healthy patent outflow tract distal to the knee in continuity 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.

5) 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 who receive intervention in both lower extremities may be enrolled in order of time of intracavitary treatment 9) For combined aortoiliac artery lesions that have undergone endoluminal revascularization to achieve flow recanalization without more than 50% residual stenosis.

Exclusion Criteria:

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

3) Patients who have been enrolled in medications that interfere with this clinical trial within the last 3 months or who have been treated intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, and so on; 4) Pregnant and lactating women 5) Patients who are unable or unwilling to participate in this trial. 6) patients with Berger's disease 7) patients who have received arterial bypass diversion on the treated side

Primary outcomes:
measure: Procedural Success Rate
timeFrame: procedural
Secondary outcomes:
measure: Primary Patency Rate
timeFrame: 30 days
measure: Freedom from clinically-driven target lesion revascularization(CD-TLR)
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Clinical improvement
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Vascular quality of life questionnaire(VascuQol)
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Remedial stenting rate
timeFrame: procedural
measure: Remedial stenting rate
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Instrument success
timeFrame: procedural
measure: Incidence of Major Adverse Events at 30 days postoperatively
timeFrame: 30 days
measure: Major adverse events
timeFrame: 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: