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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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101 Patients with Below The Knee Artery stenosis or occlusion in Experimental Group

Patients in this group use Drug eluting Balloon (Zylox-tonbridge), this is the product to be test in this clinical trail. The drug we coated is paclitaxel.

Group Type EXPERIMENTAL

Drug eluting Balloon

Intervention Type DEVICE

Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

101 Patients with Below The Knee Artery stenosis or occlusion in Controlled Group

Patients in this group use Drug eluting Balloon(Acotec), this is a product that has got approved by NMPA in 2016.

Group Type ACTIVE_COMPARATOR

Drug eluting Balloon

Intervention Type DEVICE

Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

Interventions

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Drug eluting Balloon

Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junmin Bao

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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