Clinical trial NCT06636968: A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Official title: A Real-world Study to Evaluate the Effectiveness of Intravascular Lithotripsy in Moderate to Severe Calcification Lesion of Lower Extremity Femoropopliteal Artery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Peripheral Arterial Disease
Keywords: calcification lesion
intravascular lithotripsy
lower-extremity arterial disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Huashan Hospital
name: Dongfang Hospital Affiliated to Tongji University
name: Xuanwu Hospital, Beijing
name: Qingdao Haici Hospital
name: Second Affiliated Hospital of Soochow University
name: First Affiliated Hospital of Fujian Medical University
name: Quanzhou First Hospital
name: The Second Affiliated Hospital of Hainan Medical University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: First Hospital of China Medical University
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) Age more than 18 years old; (2) Smoking, diabetes, hypertension, hyperlipidemia and other high risk factors; (3) Clinical manifestations of lower extremity arteriosclerosis obliterans; (4) The distal artery pulsation of the ischemic limb is weakened or disappeared (5)ABI≤0.9; (6) Color Doppler ultrasound, CT angiography (CTA), magnetic resonance angiography (MR angiography) and Digital subtraction angiography (Digital subtraction angiography) angiography, Imaging tests such as DSA showed the stenosis or occlusion of the corresponding arteries. (6)Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success rate
timeFrame: 7 Days
Secondary outcomes:
measure: Bailout stent
timeFrame: 7 Days
measure: Composite MAEs and embolization
timeFrame: 1 month
measure: operation-associated arterial embolization
timeFrame: 7 Days
measure: Dissection severity
timeFrame: 1 Day
measure: Dissection severity-last
timeFrame: 1 Day
measure: Major amputation
timeFrame: 1 year
measure: Primary patency
timeFrame: 1 year
measure: Freedom from TLR
timeFrame: 1 year
measure: Rutherford category
timeFrame: 1 year
measure: quality of life score
timeFrame: 1 year
measure: Indicators of health economics
timeFrame: 7 Days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
citation: Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.
citation: Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, Eschenbach G, Hartmann H, Lange C, Schnorr B, Stiepani H, Zoccai GB, Hanninen EL. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012 Dec;5(6):831-40. doi: 10.1161/CIRCINTERVENTIONS.112.971630. Epub 2012 Nov 27.
citation: Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.
citation: Jia X, Zhang J, Zhuang B, Fu W, Wu D, Wang F, Zhao Y, Guo P, Bi W, Wang S, Guo W. Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study in Femoropopliteal Arteries: Evidence From the AcoArt I Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1941-9. doi: 10.1016/j.jcin.2016.06.055.
citation: Tarricone A, Ali Z, Rajamanickam A, Gujja K, Kapur V, Purushothaman KR, Purushothaman M, Vasquez M, Zalewski A, Parides M, Overbey J, Wiley J, Krishnan P. Histopathological Evidence of Adventitial or Medial Injury Is a Strong Predictor of Restenosis During Directional Atherectomy for Peripheral Artery Disease. J Endovasc Ther. 2015 Oct;22(5):712-5. doi: 10.1177/1526602815597683. Epub 2015 Jul 24.
citation: Iida O, Takahara M, Soga Y, Hirano K, Yamauchi Y, Zen K, Yokoi H, Uematsu M; ZEPHYR investigators. Incidence and its characteristics of repetition of reintervention after drug-eluting stent implantation for femoropopliteal lesion. J Vasc Surg. 2016 Dec;64(6):1691-1695.e1. doi: 10.1016/j.jvs.2016.05.074. Epub 2016 Aug 27.
citation: Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents. JACC Cardiovasc Interv. 2013 Mar;6(3):274-81. doi: 10.1016/j.jcin.2012.12.118.
citation: Dominguez A 3rd, Bahadorani J, Reeves R, Mahmud E, Patel M. Endovascular therapy for critical limb ischemia. Expert Rev Cardiovasc Ther. 2015 Apr;13(4):429-44. doi: 10.1586/14779072.2015.1019472. Epub 2015 Mar 2.
citation: Xu Z, Ran X. Diabetic foot care in China: challenges and strategy. Lancet Diabetes Endocrinol. 2016 Apr;4(4):297-8. doi: 10.1016/S2213-8587(16)00051-6. No abstract available.
citation: Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
citation: Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.