Status:
COMPLETED
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01849601
Start Date
December 1 2012
End Date
March 1 2013
Last Update
March 23 2015
Active Locations (1)
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1
Wei Guo
Beijing, China, 100853