Peripheral Arterial DiseaseDEFINITIVE ARNCT01366482
Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease
A study testing Cotavance Drug-Eluting Balloon and TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon in people with Peripheral Arterial Disease and Claudication, run by Medtronic Endovascular at 1 site in Belgium.
Trial summary
The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication
- What is being tested?
- Cotavance Drug-Eluting Balloon and TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2011to May 2014
- 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
- Rutherford Clinical Category 2-4
- At least 18 years of age
- Is able and willing to provide written informed consent prior to study specific procedures
Who cannot join
- Has a life expectancy of less than 24 months
- Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
- Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.
- Conditions
- Peripheral Arterial Disease, Claudication
- Being tested
- Cotavance Drug-Eluting Balloon, TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
- Keywords
- Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cotavance Drug-Eluting BalloonDevice
Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)
TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonDevice
Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon
TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonDevice
Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting balloon | Experimental | Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon Receives: Device: Cotavance Drug-Eluting Balloon |
| Plaque excision + drug-eluting balloon | Experimental | Subjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon Receives: Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon |
| Severely Ca++ Group | Experimental | Subjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon Receives: Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Percent Stenosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MEDRAD, Inc.
- Responsible party
- Sponsor
- Investigators
- Professor Thomas Zeller, Principal investigator, Herz-Zentrum Bad Krozingen GermanyProfessor Gunnar Tepe, Principal investigator, Klinikum Rosenheim Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366482
- Sponsor's protocol ID
- P-4941
- Acronym
- DEFINITIVE AR
- Status last verified
- May 2019
- First submitted
- 2 Jun 2011
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
PubMed 28916599
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
- ClinicalTrials.gov ID
- NCT01366482
- Acronym / sponsor ID
- DEFINITIVE AR / P-4941
- Conditions
- Peripheral Arterial Disease, Claudication
- Keywords
- Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Collaborators
- MEDRAD, Inc.
- Study start
- Jul 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jun 2011 (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 DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting balloon | Experimental | Device: Cotavance Drug-Eluting BalloonSubjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon |
| Plaque excision + drug-eluting balloon | Experimental | Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonSubjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon |
| Severely Ca++ Group | Experimental | Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonSubjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance 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)
- Rutherford Clinical Category 2-4
- At least 18 years of age
- Is able and willing to provide written informed consent prior to study specific procedures
Key exclusion criteria (3 listed)
- Has a life expectancy of less than 24 months
- Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
- Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs
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 |
|---|---|---|
| Cotavance Drug-Eluting BalloonTreatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision) | Device | Drug-eluting balloon |
| TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonPlaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon | Device | Plaque excision + drug-eluting balloon |
| TurboHawk/SilverHawk + Cotavance Drug-Eluting BalloonPlaque excision followed by treatment with a paclitaxel-coated angioplasty balloon | Device | Severely Ca++ Group |
Primary outcome
Target Lesion Percent Stenosis
Time frame: 1 year
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 29 May 2019.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 28916599Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
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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.
Professor Thomas Zeller principal investigator
Herz-Zentrum Bad Krozingen Germany
Professor Gunnar Tepe principal investigator
Klinikum Rosenheim Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cotavance Drug-Eluting Balloon and TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon in people with Peripheral Arterial Disease and Claudication, run by Medtronic Endovascular at 1 site in Belgium.
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: finished, as of the sponsor's last update on 29 May 2019. 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 Belgium. 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?
Target Lesion Percent Stenosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366482, which also lists 2 linked publications.
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 29 May 2019.