Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.
Interventions
DEVICEpercutaneous transluminal angioplasty balloon catheter
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| technical success rate of PTA procedure | instant | 1. successfully pass lesion(s) 2. successfully dilate lesion(s)( diameter of balloon reach at least 90% of the nominal diameter) 3. successfully retrieve The definition of technical success rate of PTA procedure is that, all of the above 3 point are successful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety assessment | day 2 to day 10 after procedure or hospital discharge | 1. relevant balloon complications occurred during procedure(failure of balloon inflation, rupture of the balloon, failure of balloon deflation, failure of withdrawn, catheter fracture, etc.). 2. Relevant major vascular complications occurred during procedure (rupture of blood vessels and acute vascular occlusion caused by dilation). |
Countries
China
Outcome results
None listed