Arterial Occlusive DiseasesPhase 4DURAVESTNCT00289055
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.
A Phase 4 study testing stent and angioplasty in people with Arterial Occlusive Diseases, run by Cordis US Corp. at 1 site in Netherlands.
Trial summary
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- stent and angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2005to Jun 2008
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
- The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.
Who cannot join
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
- Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
- Gangrene in index limb (Rutherford category 6).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
Read the detailed description
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.
Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.
This study will be conducted at 8 investigational sites in The Netherlands.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- stent, angioplasty
- Keywords
- Peripheral Artery Occlusive Disease
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentDevice
Cordis SMART™ Nitinol Stent
angioplastyDevice
balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cordis SMART™ Nitinol Stent Receives: Device: stent |
| 2 | Active comparator | balloon angioplasty Receives: Device: angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency.
Measured: 12 months
Secondary outcomes (7)
Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.
Measured: at deployment
Procedural success defined as successful recanalization, without the occurrence of a SAE.
Measured: up to the moment haemostasis has been achieved
Procedural complications, defined as any adverse event
Measured: from start of the procedure up to the moment haemostasis has been achieved
Ankle Brachial Index.
Measured: discharge and 12 months
Treadmill test.
Measured: 12 months
Restenosis measured by Duplex Ultrasound.
Measured: 12 months
Quality of Life assessment.
Measured: baseline, 6, and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Reekers, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289055
- Sponsor's protocol ID
- EE04-01NL
- Acronym
- DURAVEST
- Status last verified
- Feb 2009
- First submitted
- 7 Feb 2006
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions
- ClinicalTrials.gov ID
- NCT00289055
- Acronym / sponsor ID
- DURAVEST / EE04-01NL
- Conditions
- Arterial Occlusive Diseases
- Keywords
- Peripheral Artery Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Feb 2006 (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 main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
Detailed description
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.
Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.
Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.
This study will be conducted at 8 investigational sites in The Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: stentCordis SMART™ Nitinol Stent |
| 2 | Active comparator | Device: angioplastyballoon angioplasty |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
- The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.
Key exclusion criteria (3 listed)
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
- Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
- Gangrene in index limb (Rutherford category 6).
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 |
|---|---|---|
| stentCordis SMART™ Nitinol Stent | Device | 1 |
| angioplastyballoon angioplasty | Device | 2 |
Primary outcome
Primary patency.
Time frame: 12 months
7 secondary outcomes
Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.
Time frame: at deployment
Procedural success defined as successful recanalization, without the occurrence of a SAE.
Time frame: up to the moment haemostasis has been achieved
Procedural complications, defined as any adverse event
Time frame: from start of the procedure up to the moment haemostasis has been achieved
Ankle Brachial Index.
Time frame: discharge and 12 months
Treadmill test.
Time frame: 12 months
Restenosis measured by Duplex Ultrasound.
Time frame: 12 months
Quality of Life assessment.
Time frame: baseline, 6, and 12 months post procedure
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
Jim Reekers, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 stent and angioplasty in people with Arterial Occlusive Diseases, run by Cordis US Corp. at 1 site in Netherlands.
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 2 inclusion and 3 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 24 Feb 2009. 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 Netherlands. 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?
The study was stopped early (reason given: lack of enrollment). 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?
Primary patency. (time frame: 12 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 24 Feb 2009.