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

NCT01849601 | Completed DMC

• 1 other identifier: acotec-01
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• technical success rate of PTA procedure

  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

  instant

Secondary Outcomes (1)

• safety assessment

  day 2 to day 10 after procedure or hospital discharge

Study Arms (1)

PTA catheter

EXPERIMENTAL

Device: percutaneous transluminal angioplasty balloon catheter

Interventions

percutaneous transluminal angioplasty balloon catheter DEVICE

Also known as: PTA catheter, trade name: Iris

PTA catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (1)

Wei Guo

Beijing, 100853, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2013
• First Posted: May 8, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 23, 2015

Record last verified: 2012-11

Locations

CN (1)