Peripheral Arterial DiseaseNCT00424450
Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound
An observational study of Peripheral Arterial Disease, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. 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?
- lower limb artery bypass surgery and percutaneous angioplasty (PTA)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Jul 2009
- 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: PAD patients
Who may be able to join
- male or females > 18 years old
- PAD Fontaine stages IIb, III or IV
- conventional angiography or magnetic resonance angiography
- a severe lesion (≥80% stenosis with a peak velocity ratio intrastenotic / prestenotic ≥4.0 in Duplex ultrasound or occlusion) has to be present in the common or external iliac, common or superficial femoral, popliteal or one or more infrapopliteal arteries, which is accessible to revascularization
- indication for revascularization, i.e. lower limb artery bypass surgery or PTA (based on the treating physician's decision)
- revascularization appointed within the next 6 weeks of study inclusion
- patients, who have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for the required follow-up
Who cannot join
- failed or incomplete revascularization
- patients with chronic heart failure NYHA IV
- patients with acute coronary syndrome
- patients with severe pulmonary hypertension
- patients who are assigned to conservative PAD treatment (according to the treating physician's decision)
- refusal or inability to give informed consent
- patients who are enrolled into another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)
Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. We hope find a new way of quantifying success or failure of invasive treatment strategies.
Read the detailed description
Contrast ultrasound perfusion imaging (CUPI) was developed at the University Hospital of Freiburg, Germany in 2005 for the assessment of skeletal muscle perfusion deficits in peripheral arterial disease (PAD). It has been reported previously by the investigators that the contrast agent wash-in is significantly prolonged in PAD with respect to the extent of disease and with respect to the degree of collateralization.
The goal of this study is to examine the effect of revascularization procedures on muscular perfusion in 15 PAD patients undergoing lower limb artery bypass surgery and 15 PAD patients undergoing percutaneous angioplasty (PTA) before and after intervention. Based on the data from a pilot study, a power calculation for an alpha = 5% with a power of 80% and an assumed standard deviation of 10 s yielded a necessary patient number of 29 per group to detect a decrease in wash-in time of 7.5 s. In this intra-individual comparison we aim to compare 30 patients pre with the same 30 patients post revascularization.
We hypothesize 1) that the contrast agent wash-in in the target muscle will significantly improve after revascularization and 2) that standard non-invasive tests such ankle-brachial index (ABI) will not correlate with the CUPI findings. The results of this trial will help to further understand the diagnostic accuracy of CUPI in quantifying limb muscle perfusion deficits.
Patients with symptomatic PAD and an indication for revascularization will undergo CUPI less than 8 weeks prior and less than 3 weeks after the revascularization procedure. A second follow-up CUPI examination is performed 3 - 6 months after the revascularization procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- lower limb artery bypass surgery, percutaneous angioplasty (PTA)
- Keywords
- contrast ultrasound, muscle perfusion
- 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.
lower limb artery bypass surgeryProcedure or surgery
Also called half of the included PAD patients undergo surgery
bypass of severe atherosclerotic vascular lesion
percutaneous angioplasty (PTA)Procedure or surgery
Also called half of included PAD patients undergo PTA
PTA of severe atherosclerotic lesion
| Study group | Role | What they receive |
|---|---|---|
| PAD patients | 30 PAD patients Receives: Procedure: lower limb artery bypass surgery; Procedure: percutaneous angioplasty (PTA) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionJan 2009
- Study completionJul 2009
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 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Duerschmied, University Hospital Freiburg
- Investigators
- Christoph Hehrlein, MD, Study chair, Department of Cardiology and Angiology, University Hospital of Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424450
- Sponsor's protocol ID
- C01-2006
- Status last verified
- Oct 2018
- First submitted
- 18 Jan 2007
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Duerschmied D, Olson L, Olschewski M, Rossknecht A, Freund G, Bode C, Hehrlein C. Contrast ultrasound perfusion imaging of lower extremities in peripheral arterial disease: a novel diagnostic method. Eur Heart J. 2006 Feb;27(3):310-5. doi: 10.1093/eurheartj/ehi636. Epub 2005 Nov 24.
PubMed 16308326
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)
- ClinicalTrials.gov ID
- NCT00424450
- Acronym / sponsor ID
- C01-2006
- Conditions
- Peripheral Arterial Disease
- Keywords
- contrast ultrasound, muscle perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Oct 2006 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Jan 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.
Contrast ultrasound perfusion imaging (CUPI) is a novel tool for the assessment of muscle perfusion deficits in peripheral arterial disease (PAD). In this study we want to examine the effect of bypass surgery and balloon angioplasty on the calf muscle blood supply. We hope find a new way of quantifying success or failure of invasive treatment strategies.
Detailed description
Contrast ultrasound perfusion imaging (CUPI) was developed at the University Hospital of Freiburg, Germany in 2005 for the assessment of skeletal muscle perfusion deficits in peripheral arterial disease (PAD). It has been reported previously by the investigators that the contrast agent wash-in is significantly prolonged in PAD with respect to the extent of disease and with respect to the degree of collateralization.
The goal of this study is to examine the effect of revascularization procedures on muscular perfusion in 15 PAD patients undergoing lower limb artery bypass surgery and 15 PAD patients undergoing percutaneous angioplasty (PTA) before and after intervention. Based on the data from a pilot study, a power calculation for an alpha = 5% with a power of 80% and an assumed standard deviation of 10 s yielded a necessary patient number of 29 per group to detect a decrease in wash-in time of 7.5 s. In this intra-individual comparison we aim to compare 30 patients pre with the same 30 patients post revascularization.
We hypothesize 1) that the contrast agent wash-in in the target muscle will significantly improve after revascularization and 2) that standard non-invasive tests such ankle-brachial index (ABI) will not correlate with the CUPI findings. The results of this trial will help to further understand the diagnostic accuracy of CUPI in quantifying limb muscle perfusion deficits.
Patients with symptomatic PAD and an indication for revascularization will undergo CUPI less than 8 weeks prior and less than 3 weeks after the revascularization procedure. A second follow-up CUPI examination is performed 3 - 6 months after the revascularization procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD patients | – | Procedure: lower limb artery bypass surgery, Procedure: percutaneous angioplasty (PTA)30 PAD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAD patients
Key inclusion criteria (7 listed)
- male or females > 18 years old
- PAD Fontaine stages IIb, III or IV
- conventional angiography or magnetic resonance angiography
- a severe lesion (≥80% stenosis with a peak velocity ratio intrastenotic / prestenotic ≥4.0 in Duplex ultrasound or occlusion) has to be present in the common or external iliac, common or superficial femoral, popliteal or one or more infrapopliteal arteries, which is accessible to revascularization
- indication for revascularization, i.e. lower limb artery bypass surgery or PTA (based on the treating physician's decision)
Key exclusion criteria (7 listed)
- failed or incomplete revascularization
- patients with chronic heart failure NYHA IV
- patients with acute coronary syndrome
- patients with severe pulmonary hypertension
- patients who are assigned to conservative PAD treatment (according to the treating physician's decision)
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 |
|---|---|---|
| lower limb artery bypass surgeryAlso: half of the included PAD patients undergo surgerybypass of severe atherosclerotic vascular lesion | Procedure or surgery | PAD patients |
| percutaneous angioplasty (PTA)Also: half of included PAD patients undergo PTAPTA of severe atherosclerotic lesion | Procedure or surgery | PAD patients |
Primary outcome
Not reported in the source record.
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 11 Oct 2018.
- Background: PubMed 16308326Duerschmied D, Olson L, Olschewski M, Rossknecht A, Freund G, Bode C, Hehrlein C. Contrast ultrasound perfusion imaging of lower extremities in peripheral arterial disease: a novel diagnostic method. Eur Heart J. 2006 Feb;27(3):310-5. doi: 10.1093/eurheartj/ehi636. Epub 2005 Nov 24.
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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.
Christoph Hehrlein, MD study chair
Department of Cardiology and Angiology, University Hospital of Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by University Hospital Freiburg at 1 site in Germany.
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 7 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: finished, as of the sponsor's last update on 11 Oct 2018. 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 Germany. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424450, 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 11 Oct 2018.