Peripheral Arterial DiseaseNCT02363894
DEFINITIVE AR Two Year Follow-up Extension Study
An observational study of Peripheral Arterial Disease, run by Medtronic Endovascular.
Trial summary
The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- Phase
- Observational
- 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
Study population: Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.
Who may be able to join
- Was a subject in DEFINITIVE AR I
- Is able and willing to provide written informated consent prior to study specific data collection.
Who cannot join
- Withdrew consent in DEFINITIVE AR I.
- Was reported dead during DEFINITIVE AR I.
About this study
Official title: Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study
The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.
- Conditions
- Peripheral Arterial Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects enrolled in DEFINITIVE AR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Event Rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Observational
- Observational model
- Cohort
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Thomas Zeller, MD, Principal investigator, Universitats Herzzentrum Freiburg - Bad Krozingen, GermanyProf. Gunnar Tepe, MD, Principal investigator, Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363894
- Sponsor's protocol ID
- CP-1009
- Status last verified
- Jan 2016
- First submitted
- 10 Feb 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study
- ClinicalTrials.gov ID
- NCT02363894
- Acronym / sponsor ID
- CP-1009
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Feb 2015 (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 DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects enrolled in DEFINITIVE AR | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.
Key inclusion criteria (2 listed)
- Was a subject in DEFINITIVE AR I
- Is able and willing to provide written informated consent prior to study specific data collection.
Key exclusion criteria (2 listed)
- Withdrew consent in DEFINITIVE AR I.
- Was reported dead during DEFINITIVE AR I.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Event Rate
Time frame: 2 years
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 2 Feb 2016.
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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.
Prof. Thomas Zeller, MD principal investigator
Universitats Herzzentrum Freiburg - Bad Krozingen, Germany
Prof. Gunnar Tepe, MD principal investigator
Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Medtronic Endovascular.
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 2 inclusion and 2 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Major Adverse Event Rate (time frame: 2 years). 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 2 Feb 2016.