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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: percutaneous transluminal angioplasty balloon catheter

• Registration Number: NCT01849601
• Lead Sponsor: Acotec Scientific Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-04-28
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTA catheter	percutaneous transluminal angioplasty balloon catheter	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Wei Guo; 🇨🇳 Beijing, China