NCT06713850 Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
| NCT ID | NCT06713850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Peripheral Artery Disease (PAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2024-12-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06713850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Artery Disease (PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713850 currently recruiting?
Yes, NCT06713850 is actively recruiting participants. Contact the research team at fengzibo@hust.edu.cn for enrollment information.
Where is the NCT06713850 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06713850 clinical trial?
NCT06713850 is sponsored by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 130 participants.