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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849601
• Other study ID #: acotec-01
• Status: Completed
• Phase: N/A
• First received: April 28, 2013
• Last updated: March 19, 2015
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2012
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• percutaneous transluminal angioplasty balloon catheter

Locations

Country	Name	City	State
China	Wei Guo	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	instant	No
Secondary	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).	day 2 to day 10 after procedure or hospital discharge	Yes