Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions

NCT06713850 | Recruiting DMC

• 1 other identifier: the SHIELD study
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease (PAD); Chronic Limb Threatening Ischemia

Keywords

Peripheral Artery Disease; Chronic Limb Threatening Ischemia; Severe calcification

Outcome Measures

Primary Outcomes (1)

• Procedural Success Rate

  Residual stenosis \<50% with no flow-limiting entrapment after study device therapy (before subsequent endovascular device therapy).

  procedural

Secondary Outcomes (9)

• Primary Patency Rate

  30 days

• Freedom from clinically-driven target lesion revascularization(CD-TLR)

  1 month, 3 months, 6 months, 12 months

• Clinical improvement

  1 month, 3 months, 6 months, 12 months

• Vascular quality of life questionnaire(VascuQol)

  1 month, 3 months, 6 months, 12 months

• Remedial stenting rate

  procedural

Interventions

Shockwave balloons DEVICE

To evaluate the effectiveness and safety of the Shockwave intraperipheral shockwave catheter system in peripheral arterial angioplasty.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PAD.

You may qualify if:

• \) 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.
• \) 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.

You may not qualify if:

• 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.
• \) 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

Sponsors & Collaborators

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

Study Sites (1)

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Calcinosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Zibo Feng, MD

CONTACT

86-13545160302; fengzibo@hust.edu.cn

Ye Du, DM

CONTACT

86-15827105515; duye@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CN (1)