Peripheral Vascular DiseaseNCT00222196
Oslo Balloon Angioplasty Versus Conservative Treatment
A study testing lifestyle, PTA in people with Peripheral Vascular Disease, run by Ullevaal University Hospital.
Trial summary
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. Read more about this study
- Who is it for?
- Ages Up to 75 days
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- lifestyle, PTA
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Dec 2004
- 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 Up to 75 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age below 75 years
- Symptoms of intermittent claudication with duration > 3 months
- ABPI <0.9
- A two-year follow-up is possible
Who cannot join
- Subjective pain-free walking distance > 400m
- Critical ischemia
- Previous vascular or endovascular surgery
- Diabetes ulcer
- Other physical disability abrogating organised exercise
- Use of warfarin
Show all 9Show fewer
- Mentally unable to give informed consent
- Renal insufficiency
- Coagulation disorders Duplex or PTA impossible
About this study
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.
The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.
Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
- Conditions
- Peripheral Vascular Disease
- Being tested
- lifestyle, PTA
- Keywords
- atherosclerosis, quality of life, pain-score, biomarkers
- Medical subject headings
- Peripheral Vascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle, PTAProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient quality of life.
Secondary outcomes (1)
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Aker, Pfizer
- Investigators
- Marthe Nylaende, MD, Principal investigator, Aker and Ullevål University Hospitals, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222196
- Sponsor's protocol ID
- OBACT
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oslo Balloon Angioplasty Versus Conservative Treatment
- ClinicalTrials.gov ID
- NCT00222196
- Acronym / sponsor ID
- OBACT
- Conditions
- Peripheral Vascular Disease
- Keywords
- atherosclerosis, quality of life, pain-score, biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Aker, Pfizer
- Study start
- Nov 2000
- Study completion
- Dec 2004
- First posted
- 22 Sep 2005 (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.
Background: Percutaneous transluminal angioplasty (PTA) has been popularized as a simple, effective and cheap treatment achieving 50-70% symptomatic patency rates in patients with peripheral occlusive disease.. However, the fact remains that the indication for performing PTA are still more based on opinions than on scientific data.
The purpose of the trial was to randomize patients primarily referred for intermittent claudication into two groups: One group was offered conservative treatment; the other group was offered conservative treatment combined with PTA.
Primary outcome: The patient quality of life. Secondary outcome:Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age below 75 years
- Symptoms of intermittent claudication with duration > 3 months
- ABPI <0.9
- A two-year follow-up is possible
Key exclusion criteria (9 listed)
- Subjective pain-free walking distance > 400m
- Critical ischemia
- Previous vascular or endovascular surgery
- Diabetes ulcer
- Other physical disability abrogating organised exercise
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 |
|---|---|---|
| lifestyle, PTA | Procedure or surgery | – |
Primary outcome
The patient quality of life.
1 secondary outcome
Pain-free walking distance; pain-score; death; amputation; changes in relevant biomarkers
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 6 Jul 2011.
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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.
Marthe Nylaende, MD principal investigator
Aker and Ullevål University Hospitals, Oslo, Norway
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle, PTA in people with Peripheral Vascular Disease, run by Ullevaal University Hospital.
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 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: finished, as of the sponsor's last update on 6 Jul 2011. 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?
The patient quality of life.. 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 6 Jul 2011.