Peripheral Artery DiseaseNCT00676494
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
A study testing Pathway PV Atherectomy System in people with Peripheral Artery Disease, run by Pathway Medical Technologies Inc..
Trial summary
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Pathway PV Atherectomy System
- Type of treatment
- Medical device
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented symptomatic atherosclerotic peripheral vascular disease
- Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
- The patient has been informed of the nature of the study and has provided informed consent
- The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits
Who cannot join
- Target lesion is located in the iliac artery.
- Target lesion stenosis is < 70%.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Patient is unable to participate for the duration of the study.
- Patient is currently participating or has participated in a study with another investigational medical device or medication.
About this study
Official title: A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.
This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.
- Conditions
- Peripheral Artery Disease
- Being tested
- Pathway PV Atherectomy System
- 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.
Pathway PV Atherectomy SystemDevice
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events (MAEs) Within 30 Days
Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.
Measured: 30 days
Secondary outcomes (3)
Average Rutherford Classification Score at 6 Months
Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)
Measured: 6 months
Average Ankle Brachial Index (ABI) at 6 Months
Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)
Measured: 6 months
Freedom From Target Lesion Revascularization (TLR) at 6 Months
Number of patients that did not require target lesion revascularization 6 months after index procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startFeb 2006
- Primary completionJul 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pathway Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Zeller, MD, Principal investigator, Herz Zentrum Bad Krozingen, GermanyDierk Scheinert, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676494
- Sponsor's protocol ID
- PTC 05003
- Status last verified
- May 2009
- First submitted
- 8 May 2008
- Last updated
- 9 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.
PubMed 19995118
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions
- ClinicalTrials.gov ID
- NCT00676494
- Acronym / sponsor ID
- PTC 05003
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Pathway Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 9 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.
This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented symptomatic atherosclerotic peripheral vascular disease
- Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
- The patient has been informed of the nature of the study and has provided informed consent
- The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits
Key exclusion criteria (5 listed)
- Target lesion is located in the iliac artery.
- Target lesion stenosis is < 70%.
- Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- Patient is unable to participate for the duration of the study.
- Patient is currently participating or has participated in a study with another investigational medical device or medication.
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 |
|---|---|---|
| Pathway PV Atherectomy SystemThe Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures. | Device | – |
Primary outcome
Major Adverse Events (MAEs) Within 30 Days
Time frame: 30 days
Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.
3 secondary outcomes
Average Rutherford Classification Score at 6 Months
Time frame: 6 months
Average Ankle Brachial Index (ABI) at 6 Months
Time frame: 6 months
Freedom From Target Lesion Revascularization (TLR) at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19995118Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.
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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.
Thomas Zeller, MD principal investigator
Herz Zentrum Bad Krozingen, Germany
Dierk Scheinert, MD principal investigator
University of Leipzig
Questions about this trial
What is this clinical trial studying?
A study testing Pathway PV Atherectomy System in people with Peripheral Artery Disease, run by Pathway Medical Technologies Inc..
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 4 inclusion and 5 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 9 Jul 2009. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Events (MAEs) Within 30 Days (time frame: 30 days). 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 NCT00676494, which also lists 1 linked publication.
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 Jul 2009.