A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease

• Registration Number: NCT05415995
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief Summary

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Detailed Description

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-10
• Last Update Submitted: 2022-06-10
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Age 18-85 years；
• ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
• Rutherford Category 3-6；
• Subjects are willing to sign informed consent；

Exclusion Criteria

• Planned major limb amputation within 30 days after the procedure;
• In-stent stenosis in the target lesion;
• Severely calcified target lesions；
• Creatinine>2.5mg/dL;
• History of allergies to anesthetics, contrast agents；
• Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
• Other circumstances judged by researchers that are not suitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of primary patency of the target lesion	180 days	Primary patency is defined as no target lesion occlusion, no clinical symptom driven target lesion revascularization and major limb amputation.

Secondary Outcome Measures

Name	Time	Method
Success rate of the technique	Immediately after the intervention	On the basis of device success,technique success rate is defined as restored blood flow in the lesion after the treatment, and the residual stenosis ≤30%.
Success rate of the device	Intraoperation	Success rate of the device is defined as a situation that the balloon catheter reached the lesion site, dilated successfully without rupture, and was successfully withdrawn.
Success rate of the operation	Within 7 days	On the basis of technique success, operation success is defined as no adverse event happening.

Trial Locations

Locations (20)

The second hospital of Anhui Medical university; 🇨🇳 Hefei, Anhui, China

Zhongshan Hospital Xiamen University; 🇨🇳 Xiamen, Fujian, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

HeNan Province People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital Of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The central hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital Of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

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