Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure

Acotec Scientific

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: percutaneous transluminal angioplasty balloon catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT01849601

acotec-01

Details and patient eligibility

About

The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.

Enrollment

167 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 18 yrs - 80 yrs.
patients with iliac and / or femoral artery atherosclerotic lesions
Rutherford grade of 1-5;
Target lesion stenosis≥70% (visual estimation) (proportion of Trans-Atlantic Inter-Society Consensus(TASC) B, C and D grade lesions not less than 60% )
Patients being able to understand the purpose of the test, and being volunteered to participate in and sign the informed consent.

Exclusion criteria

Patients not suitable for receiving interventional surgeries of lower limb arteries for treatment;
Patients require intervention of lesions besides unilateral iliac and femoral artery lesions at the same time;
Patients have been involved in clinical trials of other drugs or medical devices within the past three months;
Patient is unable or unwilling to participate in this trial;
Patients with serious heart and brain, liver and other vital organs failure;
Patients with life expectancy less than 6 months;
Pregnant women.