In-stent Arterial RestenosisNCT01616888
Paclitaxel Eluting Balloon for SFA In-stent Restenosis
A study testing PTA with drug eluting balloon with paclitaxel in people with In-stent Arterial Restenosis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Arterial Restenosis
- What is being tested?
- PTA with drug eluting balloon with paclitaxel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
- in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm
Who cannot join
- participation in another investigational drug or device trial
- life expectancy less than 12 months
- acute ischemia and/or acute thrombosis of the SFA/PPA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.
Read the detailed description
Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.
- Conditions
- In-stent Arterial Restenosis
- Being tested
- PTA with drug eluting balloon with paclitaxel
- Keywords
- drug eluting balloon with paclitaxel, in stent restenosis, femoropopliteal arteries, angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA with drug eluting balloon with paclitaxelDevice
Also called In.Pact Admiral by Medtronic
Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | SFA angioplasty with In.Pact Admiral drug eluting balloon Receives: Device: PTA with drug eluting balloon with paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion patency at 6-month follow-up.
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
Measured: 6-month post index procedure
Secondary outcomes (1)
Clinical success up to 12 months post index procedure
Improvement on clinical evaluations including staging of PAD according to the Rutherford category, ABI at 1, 6, 12 months post procedure compared to baseline assessment.
Measured: 12 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Arterial RestenosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kong Teng Tan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616888
- Sponsor's protocol ID
- KTT2
- Status last verified
- Dec 2014
- First submitted
- 7 Jun 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT01616888
- Acronym / sponsor ID
- KTT2
- Conditions
- In-stent Arterial Restenosis
- Keywords
- drug eluting balloon with paclitaxel, in stent restenosis, femoropopliteal arteries, angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 12 Jun 2012 (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 the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.
Detailed description
Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Device: PTA with drug eluting balloon with paclitaxelSFA angioplasty with In.Pact Admiral drug eluting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
- in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm
Key exclusion criteria (3 listed)
- participation in another investigational drug or device trial
- life expectancy less than 12 months
- acute ischemia and/or acute thrombosis of the SFA/PPA
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 |
|---|---|---|
| PTA with drug eluting balloon with paclitaxelAlso: In.Pact Admiral by MedtronicAngioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries | Device | Treatment arm |
Primary outcome
Target lesion patency at 6-month follow-up.
Time frame: 6-month post index procedure
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
1 secondary outcome
Clinical success up to 12 months post index procedure
Time frame: 12 months post index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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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.
Kong Teng Tan, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTA with drug eluting balloon with paclitaxel in people with In-stent Arterial Restenosis, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Dec 2014. 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 Canada. 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?
Results are not available in the source record.
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?
Target lesion patency at 6-month follow-up. (time frame: 6-month post index procedure). 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 9 Dec 2014.