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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01849601
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: percutaneous transluminal angioplasty balloon catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter and Single-arm Target Value Clinical Study on the Efficacy and Safety of Peripheral Balloon Dilatation Catheter in PTA Procedure
Study Start Date : December 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTA catheter Device: percutaneous transluminal angioplasty balloon catheter
Other Names:
  • PTA catheter
  • trade name: Iris




Primary Outcome Measures :
  1. technical success rate of PTA procedure [ Time Frame: 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 :
  1. safety assessment [ Time Frame: 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during procedure(failure of balloon inflation, rupture of the balloon, failure of balloon deflation, failure of withdrawn, catheter fracture, etc.).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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849601


Locations
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China
Wei Guo
Beijing, China, 100853
Sponsors and Collaborators
Acotec Scientific Co., Ltd

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Responsible Party: Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier: NCT01849601     History of Changes
Other Study ID Numbers: acotec-01
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: November 2012

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases