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

NCT ID: NCT01849601

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTA catheter

Group Type: EXPERIMENTAL

percutaneous transluminal angioplasty balloon catheter

Intervention Type: DEVICE

Interventions

percutaneous transluminal angioplasty balloon catheter

Intervention Type: DEVICE

Other Intervention Names

PTA catheter; trade name: Iris

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acotec Scientific Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wei Guo

Beijing, , China

Countries

China

Other Identifiers

acotec-01

Identifier Type: -

Identifier Source: org_study_id