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Completed

NCT Number: NCT01849601

Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wei Guo

Beijing, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

percutaneous transluminal angioplasty balloon catheter

Device

Other names: PTA catheter, trade name: Iris

Primary outcomes

  1. technical success rate of PTA procedure

    Time frame: instant

    • 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

Secondary outcomes

  1. safety assessment

    Time frame: day 2 to day 10 after procedure or hospital discharge

    • 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).

Sponsors and collaborators

Lead sponsor

Acotec Scientific Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2013
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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