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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
percutaneous transluminal angioplasty balloon catheter
Sponsored by
Acotec Scientific Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wei Guo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTA catheter

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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during procedure(failure of balloon inflation, rupture of the balloon, failure of balloon deflation, failure of withdrawn, catheter fracture, etc.).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).

Full Information

First Posted
April 28, 2013
Last Updated
March 19, 2015
Sponsor
Acotec Scientific Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01849601
Brief Title
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTA catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
percutaneous transluminal angioplasty balloon catheter
Other Intervention Name(s)
PTA catheter, trade name: Iris
Primary Outcome Measure Information:
Title
technical success rate of PTA procedure
Description
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
Time Frame
instant
Secondary Outcome Measure Information:
Title
safety assessment
Description
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).
Time Frame
day 2 to day 10 after procedure or hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Wei Guo
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

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

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