Peripheral Arterial DiseasePhase 4PESETANCT02033135
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis
A Phase 4 study testing Angioplasty with Zilver PTX, Best medical treatment and Zilver PTX in people with Peripheral Arterial Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis. Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Angioplasty with Zilver PTX, Best medical treatment and Zilver PTX
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Aug 2017
- Phase
- Phase 4
- 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
- Patient has signed and dated the informed consent.
- Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.
- Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
- Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
- Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)
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- Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.
- Patient has a resting ABI <0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a TBI <0.8.
- Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.
Who cannot join
- Patient is pregnant, breast-feeding or under 18 years of age.
- Patient unable to understand and sign informed consent forms
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.
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- Patient 2-3 patent crural vessel runoff with <50% stenosis throughout its course.
- Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI > 40
- Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia
Trial locations and contacts
1 site in 1 country.
Torben V Schroeder, MD, MDSc contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Østerbro, 2100
Lise Pyndt, MD, +45 35457458, lpyndt@gmail.com
Lise Pyndt, MD
About this study
Official title: Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.
Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Angioplasty with Zilver PTX, Best medical treatment, Zilver PTX
- Keywords
- Atherosclerosis, Intermittent claudication, Angioplasty
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty with Zilver PTXProcedure or surgery
Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)
Best medical treatmentOther
Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.
Zilver PTXDevice
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty with Zilver PTX | Experimental | Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy. Receives: Procedure: Angioplasty with Zilver PTX; Other: Best medical treatment; Device: Zilver PTX |
| Best medical treatment | Active comparator | Unsupervised exercise therapy, smoking cessation advice and best medical therapy. Receives: Other: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance
Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.
Measured: 24 months
Secondary outcomes (3)
Ankle brachial pressure indices
a measure of the peripheral bloodpressure
Measured: 24 months
Quality of life
Quality of life is evaluated by using questionnaires
Measured: 24 months
Cost of the treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2015 (estimated)
- Study completionAug 2017 (estimated)
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Pyndt Jørgensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Torben V Schroeder, MD, MDSc, Study director, Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033135
- Sponsor's protocol ID
- H 4 2012 027
- Acronym
- PESETA
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
- ClinicalTrials.gov ID
- NCT02033135
- Acronym / sponsor ID
- PESETA / H 4 2012 027
- Conditions
- Peripheral Arterial Disease
- Keywords
- Atherosclerosis, Intermittent claudication, Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 Jan 2014 (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.
This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.
Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angioplasty with Zilver PTX | Experimental | Procedure: Angioplasty with Zilver PTX, Other: Best medical treatment, Device: Zilver PTXAngioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy. |
| Best medical treatment | Active comparator | Other: Best medical treatmentUnsupervised exercise therapy, smoking cessation advice and best medical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient has signed and dated the informed consent.
- Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.
- Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
- Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
- Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
Key exclusion criteria (9 listed)
- Patient is pregnant, breast-feeding or under 18 years of age.
- Patient unable to understand and sign informed consent forms
- Patient is simultaneously participating in another investigational drug or device study.
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
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 |
|---|---|---|
| Angioplasty with Zilver PTXAngioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) | Procedure or surgery | Angioplasty with Zilver PTX |
| Best medical treatmentTreatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise. | Other | Angioplasty with Zilver PTX, Best medical treatment |
| Zilver PTX | Device | Angioplasty with Zilver PTX |
Primary outcome
Maximal walking distance
Time frame: 24 months
Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.
3 secondary outcomes
Ankle brachial pressure indices
Time frame: 24 months
Quality of life
Time frame: 24 months
Cost of the treatment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Torben V Schroeder, MD, MDSc contact
Torben V Schroeder, MD, MDSc study director
Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angioplasty with Zilver PTX, Best medical treatment and Zilver PTX in people with Peripheral Arterial Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 inclusion and 9 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 10 Jan 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lise P Jørgensen, MD, (+45 3545 3654, lpyndt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal walking distance (time frame: 24 months). 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 10 Jan 2014.