A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery

Active, not recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06636968
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Vascular calcification is prevalent in patients with Peripheral artery disease (PAD), especially those with combined diabetes or chronic kidney disease. Severe calcification predicts poor prognosis and is independently associated with increased risk of cardiovascular death and morbidity. Calcification may also affect the outcome of endovascular therapy, leading to unsatisfactory vasodilation, and increase the risk of vascular complications (including restenosis) and dissection, perforation, and distal embolization. At present, according to the degree of calcification and the scope of the lesion, it can be divided into light, medium and severe three grades. Neither high pressure balloon nor atherectomy can significantly improve severe calcification. The efficacy of these treatments has also not been tested in multicenter, real-world studies. Shockwave balloon has been widely used in the clinical treatment of severe calcification due to its characteristics of significantly destroying the calcification structure, reducing the damage of vascular intima, and thus reducing postoperative complications. The currently published Disrupt PAD III Trial (NCT02923193) in calcified lesions showed shock wave balloon versus balloon expansion alone in a randomized controlled trial (RCT). The residual stenosis rate was lower (66.4% vs. 51.9%; p = 0.02), the incidence of fluid limiting intersections was low (1.4% vs. 6.8%; p = 0.03), the rate of post-expansion and recovery support was also low (5.2% vs. 17.0%; p = 0.001); (4.6% vs. 18.3%; p \< 0.001). The shock wave balloon has been approved by the China Food and Drug Administration for the intracavitary treatment of severe femoral popliteal artery calcification. Due to its short market-time, it is currently only used in large vascular surgery centers. On this basis, investigators propose whether can set up a real-world study of shock wave balloon in the treatment of moderate and severe calcification, in order to explore the real efficacy of shock wave balloon in the treatment of moderate and severe calcification.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients older than 18 years
• Rutherford scale: Grades 2-5.
• Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
• The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
• At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
• The stenosis degree of inflow blood vessel on the diseased side is less than 30% or the residual stenosis is less than 30% after first-stage treatment.
• Calcification lesions with thrombus can also be included in the group after the thrombus is completely cleared.
• Sign relevant informed consent.

Exclusion Criteria

• Active infection of the affected limb.
• Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
• The target blood vessels were artificial blood vessels or autologous vessels.
• Simple thrombosis lesion.
• Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
• Inflow vessel stenosis is greater than 30% or residual stenosis is still greater than 30% after primary treatment.
• Allergic to contrast agent, heparin, anti-platelet therapy.
• Patients who are pregnant or lactating.
• Patients with cardiovascular and cerebrovascular events such as stroke or myocardial infarction within 3 months prior to enrollment.
• Patients who are currently in an ongoing interventional clinical study program.
• Patients who refuse to sign informed consent. •
• Patients who refuse to cooperate with long-term follow-up after surgery or who, for personal reasons, have difficulty communicating for quality of life assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success rate	7 Days	Defined as a final residual stenosis of less than 30% without a significant dissection (grade ≥D)

Secondary Outcome Measures

Name	Time	Method
Bailout stent	7 Days	The rate of bailout stent implantation.
Composite MAEs and embolization	1 month	Composite end point of major amputation plus operation-associated arterial embolization.
operation-associated arterial embolization	7 Days	Perioperative operation-associated arterial embolization
Dissection severity	1 Day	Dissection after major procedure
Dissection severity-last	1 Day	Dissection after last procesure
Major amputation	1 year	Major amputation rate in different frame
Primary patency	1 year	Primary patency in different frame
Freedom from TLR	1 year	Freedom from TLR in different frame
Rutherford category	1 year	Rutherford grading improvement score after surgery（Rutherford Classification,0-6, higher scores mean a worse outcome）
quality of life score	1 year	Postoperative quality of life score(15-items quality of recovery scale after, 0-150, higher scores mean a better outcome)
Indicators of health economics	7 Days	Cumulative hospitalization costs associated with target lesions and costs associated with endovascular therapy.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China