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

Zhejiang Zylox Medical Device

Status: Enrolling

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Device: Drug eluting Balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT05498740

04202106

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

drug eluting balloon catheter

Experimental group

Description:

use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Treatment:

Device: Drug eluting Balloon