Peripheral Vascular DiseasePhase 4NCT00437905
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
A Phase 4 study testing angioplasty in people with Peripheral Vascular Disease and Intermittent Claudication, run by Medical University of Vienna.
Trial summary
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Intermittent Claudication, Atherosclerosis
- What is being tested?
- angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jan 2007
- 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
- Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length
Who cannot join
- Previous bypass surgery at the site of treatment,
- Previous stent placement at or immediatly adjacent to target lesion,
- History of anti-platelet-therapy intolerance or adverse reaction to heparin,
- Bleeding diathesis,
- Creatinine > 2,5 mg/dL,
- Active bacterial infection,
- Allergy to contrast media
About this study
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
Read the detailed description
Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment.
With the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation.
The promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or critical limb ischemia.
- Being tested
- angioplasty
- Keywords
- peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
Secondary outcomes (1)
occurence of restenosis within 6 months after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJun 2003
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Jasmin Amighi, MD, Principal investigator, Medical University of ViennaMartin Schillinger, MD, Principal investigator, Medical University of ViennaManfred Cejna, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437905
- Sponsor's protocol ID
- Version 2.0-12/2003
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No
Publications
Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial. Radiology. 2008 Apr;247(1):267-72. doi: 10.1148/radiol.2471070749. Epub 2008 Feb 12.
PubMed 18270378
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00437905
- Acronym / sponsor ID
- Version 2.0-12/2003
- Keywords
- peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Jan 2007
- First posted
- 21 Feb 2007 (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 study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
Detailed description
Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment.
With the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation.
The promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (1 listed)
- Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length
Key exclusion criteria (7 listed)
- Previous bypass surgery at the site of treatment,
- Previous stent placement at or immediatly adjacent to target lesion,
- History of anti-platelet-therapy intolerance or adverse reaction to heparin,
- Bleeding diathesis,
- Creatinine > 2,5 mg/dL,
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 | Procedure or surgery | – |
Primary outcome
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
1 secondary outcome
occurence of restenosis within 6 months after endovascular treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
- Derived from this study: PubMed 18270378Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial. Radiology. 2008 Apr;247(1):267-72. doi: 10.1148/radiol.2471070749. Epub 2008 Feb 12.
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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.
Jasmin Amighi, MD principal investigator
Medical University of Vienna
Martin Schillinger, MD principal investigator
Medical University of Vienna
Manfred Cejna, MD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing angioplasty in people with Peripheral Vascular Disease and Intermittent Claudication, run by Medical University of Vienna.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Feb 2007. 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.
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?
The study was stopped early. Results are not available in the source record.
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?
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP). 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 NCT00437905, 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 21 Feb 2007.