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

Peripheral Arterial Disease (PAD) Clinical Trial

— UltraFuture I  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498740
• Other study ID #: 04202106
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: Jie Liang
• Phone: 13819565660
• Email: jie.liang[@]zyloxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	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	First Hospital of Lanzhou University	Lanzhou
China	Ningbo huamei hospital	Ningbo
China	Qingdao Municipal Hospital	Qingdao
China	Ruian People's Hospital	Rui'an
China	Shanghai Ninth People'S Hospital	Shanghai
China	Zhongshan Hospital	Shanghai
China	Northern Theatre General Hospital	Shenyang
China	Tianjin Medical University General Hospital	Tianjin
China	Tianjin People's Hospital	Tianjin
China	Weifang People's Hospital	Weifang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine	Xi'an
China	People's Hospital of Xinjiang Uygur Autonomous Region	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of device success		intraoperative
Primary	rate of procedural success		intraoperative
Primary	rate of technical success		intraoperative
Primary	rate of primary patency of target lesion		12 months
Primary	rate of primary patency of target lesion		24 months
Primary	rate of Clinically-driven TLR		12 months
Primary	rate of Clinically-driven TLR		24 months
Primary	rate of TLR		1 month
Primary	rate of TLR		12 months
Primary	rate of TLR		24 months
Primary	rate of Clinically-driven TVR		12 months
Primary	rate of Clinically-driven TVR		24 months
Primary	rate of TVR		1 month
Primary	rate of TVR		12 months
Primary	rate of TVR		24 months
Primary	change in Rutherford clinical category (target limb)		12 months
Primary	change in Rutherford clinical category (target limb)		24 months
Primary	change in ankle brachial index(ABI)		12 months
Primary	change in ankle brachial index(ABI)		24 months
Primary	rate of SAE		12 months
Primary	rate of SAE		24 months
Primary	rate of All-cause mortality		1 month
Primary	rate of All-cause mortality		12 months
Primary	rate of All-cause mortality		24 months
Primary	rate of Major amputation		1 month
Primary	rate of Major amputation		12 months
Primary	rate of Major amputation		24 months
Primary	rate of target lesion thrombosis		12 months
Primary	rate of target lesion thrombosis		24 months
Primary	Rate of adverse events		intraoperative
Primary	Rate of adverse events		1 month
Primary	Rate of adverse events		12 months
Primary	Rate of adverse events		24 months