Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions (SHIELD)

Real-World Clinical Evaluation of the Shockwave Intravascular Lithotripsy (IVL) Catheter System for Treating Severe Calcified Lesions in Femoropopliteal Arteries

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Limb Threatening Ischemia; Peripheral Artery Disease (PAD)
• Intervention / Treatment: Device: Shockwave balloons

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 Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Zibo Feng, MD; Phone Number: 86-13545160302; Email: fengzibo@hust.edu.cn
• Study Contact Backup: Name: Ye Du, DM; Phone Number: 86-15827105515; Email: duye@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Zibo Feng, MD; Phone Number: 86-13545160302; Email: fengzibo@hust.edu.cn
      • Contact: Ye Du, MD; Phone Number: 86-15827105515; Email: duye@hust.edu.cn
      • Sub-Investigator: Youpeng Zhu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PAD.

Description

Inclusion Criteria:

-

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success Rate	Residual stenosis <50% with no flow-limiting entrapment after study device therapy (before subsequent endovascular device therapy).	procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate	Primary patency of target lesions at 30 days postoperatively	30 days
Freedom from clinically-driven target lesion revascularization(CD-TLR)	Clinically driven target lesion revascularization is defined as target lesion revascularization performed due to target lesion diameter stenosis ≥50% and either evidence of clinical or functional ischemia (e.g., recurrent/progressive life-limiting intermittent claudication, claudication unresponsive to medical therapy, CLI) or recurrence of the clinical syndrome for which the initial procedure was performed.	1 month, 3 months, 6 months, 12 months
Clinical improvement	Improvements in Rutherford grading	1 month, 3 months, 6 months, 12 months
Vascular quality of life questionnaire(VascuQol)	The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.	1 month, 3 months, 6 months, 12 months
Remedial stenting rate	Remedial stenting rate	procedural
Remedial stenting rate	Manipulation-related acute thrombosis, arterial embolism, major amputation, and all-cause mortality	1 month, 3 months, 6 months, 12 months
Instrument success	Successful delivery and deployment of a single-use peripheral intravascular shockwave catheter to the intended target lesion site and successful withdrawal of the delivery system	procedural
Incidence of Major Adverse Events at 30 days postoperatively	a Emergency surgical hemodialysis of the target limb; b.Unplanned target limb amputation (above the ankle); c.Symptomatic thrombosis or distal embolization requiring treatment in the area of the target lesion or in the target limb as confirmed by imaging; d.Perforation or flow-limiting entrapment of the target lesion requiring treatment; cardiac death.	30 days
Major adverse events	Death, unplanned major amputation of the target limb, and CD-TLR were defined as a major adverse event.	1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
• Collaborators: Shanghai Zhongshan Hospital; RenJi Hospital; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; Xuanwu Hospital, Beijing; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; The General Hospital of Southern Theater Command

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Chronic Limb Threatening Ischemia; Severe calcification
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Ischemia; Peripheral Arterial Disease
• Other Study ID Numbers: the SHIELD study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is a multi-center real-world study and the data will be shared among several of the participating centers. For non-participants who need to use the data, consent from all participating units will be required before use.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No