Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease (PAD)

• Registration Number: NCT05498740
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-04
• Study First Submitted: 2022-07-22
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

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

Inclusion Criteria

1. Age ≥18 years old and ≤85 years old
2. Rutherford clinical category classification：2-5
3. Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria

1. Aneurysms near target lesions or popliteal aneurysms.
2. The guide wire cannot pass smoothly through the target lesion.
3. Known allergy to contrast agents, heparin or paclitaxel.
4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
rate of TLR	24 months
rate of Clinically-driven TLR	24 months
rate of TVR	24 months
rate of SAE	24 months
rate of Major amputation	24 months
rate of device success	intraoperative
change in ankle brachial index(ABI)	24 months
rate of All-cause mortality	24 months
rate of target lesion thrombosis	24 months
Rate of adverse events	24 months
change in Rutherford clinical category (target limb)	24 months
rate of technical success	intraoperative
rate of Clinically-driven TVR	24 months
rate of primary patency of target lesion	24 months
rate of procedural success	intraoperative

Trial Locations

Locations (24)

Xuanwu hospital; 🇨🇳 Beijing, China

Affiliated Hospital of Chengde Medical College; 🇨🇳 Chengde, China

The Third People's Hospital of Chengdu; 🇨🇳 Chengdu, China

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

The Second Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Guangzhou Huaqiao hospital; 🇨🇳 Guangzhou, China

Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University; 🇨🇳 Guangzhou, China

The Third Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Ha'erbin, China

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, China

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