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

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

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 Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: percutaneous transluminal angioplasty balloon catheter

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Wei Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PTA catheter	Device: percutaneous transluminal angioplasty balloon catheter; Other Names: PTA catheter; trade name: Iris

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: April 28, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (ESTIMATE): May 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: acotec-01