Peripheral Artery Disease (PAD)SHIELDNCT06713850
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
An observational study of Peripheral Artery Disease (PAD) and Chronic Limb Threatening Ischemia, run by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
- What is being tested?
- Shockwave balloons
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with PAD.
Who may be able to join
- -
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Zibo Feng, MD, 86-13545160302, fengzibo@hust.edu.cn
Ye Du, MD, 86-15827105515, duye@hust.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Shockwave balloons
- Keywords
- Peripheral Artery Disease, Chronic Limb Threatening Ischemia, Severe calcification
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave balloonsDevice
To evaluate the effectiveness and safety of the Shockwave intraperipheral shockwave catheter system in peripheral arterial angioplasty.
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success Rate
Residual stenosis <50% with no flow-limiting entrapment after study device therapy (before subsequent endovascular device therapy).
Measured: procedural
Secondary outcomes (9)
Primary Patency Rate
Primary patency of target lesions at 30 days postoperatively
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months
Clinical improvement
Improvements in Rutherford grading
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months
Remedial stenting rate
Remedial stenting rate
Measured: procedural
Remedial stenting rate
Manipulation-related acute thrombosis, arterial embolism, major amputation, and all-cause mortality
Measured: 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
Measured: 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.
Measured: 30 days
Major adverse events
Death, unplanned major amputation of the target limb, and CD-TLR were defined as a major adverse event.
Measured: 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Huashan Hospital, Xuanwu Hospital, Beijing, The General Hospital of Southern Theater Command, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Chengdu University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zibo Feng, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713850
- Sponsor's protocol ID
- the SHIELD study
- Acronym
- SHIELD
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.