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

Acotec Scientific Co., Ltd167 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

167

Conditions

Peripheral Arterial Disease

Interventions

percutaneous transluminal angioplasty balloon catheterDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wei Guo

Beijing, China

Outcomes

Primary Outcomes

technical success rate of PTA procedure

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

Time frame: instant

Secondary Outcomes

safety assessment

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during procedure(failure of balloon inflation, rupture of the balloon, failure of balloon deflation, failure of withdrawn, catheter fracture, etc.). 2.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).

Time frame: day 2 to day 10 after procedure or hospital discharge

Data from ClinicalTrials.gov

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