Peripheral Arterial DiseaseNCT01849601
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
A study testing percutaneous transluminal angioplasty balloon catheter in people with Peripheral Arterial Disease, run by Acotec Scientific Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- percutaneous transluminal angioplasty balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- percutaneous transluminal angioplasty balloon catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous transluminal angioplasty balloon catheterDevice
Also called PTA catheter, trade name: Iris
| Study group | Role | What they receive |
|---|---|---|
| PTA catheter | Experimental | Not described Receives: Device: percutaneous transluminal angioplasty balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: instant
Secondary outcomes (1)
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).
Measured: day 2 to day 10 after procedure or hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849601
- Sponsor's protocol ID
- acotec-01
- Status last verified
- Nov 2012
- First submitted
- 28 Apr 2013
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01849601
- Acronym / sponsor ID
- acotec-01
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTA catheter | Experimental | Device: percutaneous transluminal angioplasty balloon catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous transluminal angioplasty balloon catheterAlso: PTA catheter, trade name: Iris | Device | PTA catheter |
Primary outcome
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
1 secondary outcome
safety assessment
Time frame: day 2 to day 10 after procedure or hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous transluminal angioplasty balloon catheter in people with Peripheral Arterial Disease, run by Acotec Scientific Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success rate of PTA procedure (time frame: instant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.