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

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

Official Title
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A Prospective, Multicenter and Single-arm Target Value Clinical Study on the Efficacy and Safety of Peripheral Balloon Dilatation Catheter in PTA Procedure

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: percutaneous transluminal angioplasty balloon catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTA catheter<br> | Device: percutaneous transluminal angioplasty balloon catheter<br> <br> * Other names: trade name: Iris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success rate of PTA procedure | successfully pass lesion(s) successfully dilate lesion(s)( diameter of balloon reach at least 90% of the nominal diameter) successfully retrieve The definition of technical success rate of PTA procedure is that, all of the above 3 point are successful | instant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessment | relevant balloon complications occurred during procedure(failure of balloon inflation, rupture of the balloon, failure of balloon deflation, failure of withdrawn, catheter fracture, etc.). Relevant major vascular complications occurred during procedure (rupture of blood vessels and acute vascular occlusion caused by dilation). | day 2 to day 10 after procedure or hospital discharge |