Peripheral Vascular DiseasesPhase 4NCT00715416
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
A Phase 4 study testing Nitinol stent and Nitinol Stent Placement in people with Peripheral Vascular Diseases and Intermittent Claudication, run by Vienna General Hospital at 1 site in Austria.
Trial summary
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Vascular Diseases, Intermittent Claudication, Angioplasty
- What is being tested?
- Nitinol stent and Nitinol Stent Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2004to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
- critical limb ischemia in patients with stenosis or occlusions originating in the SFA
- up to 25 cm length of stenosis/occlusion
Who cannot join
- previous bypass surgery at the site of treatment
- history of intolerance of anti-platelet therapy
- adverse reaction to heparin
- bleeding diathesis
- creatinine >2.5 mg/dL
- active bacterial infection
- allergy to contrast media
- previous stent placement at or immediately adjacent to the target lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.
- Being tested
- Nitinol stent, Nitinol Stent Placement
- Keywords
- peripheral vascular diseases, Intermittent Claudication, Angioplasty
- Medical subject headings
- Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitinol stentDevice
Interventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram.
Nitinol Stent PlacementProcedure or surgery
Also called Product: peripheral stent system, Type: ASTRON, EC class: IIb, Certificate number: G1 01 10 10275 193
Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | primary nitinol stent placement of superficial femoral artery lesions Receives: Device: Nitinol stent; Procedure: Nitinol Stent Placement |
| 2 | Active comparator | balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure Receives: Device: Nitinol stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
Measured: 3, 6, 12 months
Secondary outcomes (1)
ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Martin Schilliger, Prof, Principal investigator, General Hospital of Vienna, Department of AngiologyMartin Schillinger, Prof, Principal investigator, General Hospital of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715416
- Sponsor's protocol ID
- 1.1/2006
- Status last verified
- Jan 2006
- First submitted
- 11 Jul 2008
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
PubMed 16672699
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00715416
- Acronym / sponsor ID
- 1.1/2006
- Keywords
- peripheral vascular diseases, Intermittent Claudication, Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Vienna General HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 15 Jul 2008 (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 investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.
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: Nitinol stent, Procedure: Nitinol Stent Placementprimary nitinol stent placement of superficial femoral artery lesions |
| 2 | Active comparator | Device: Nitinol stentballoon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
- critical limb ischemia in patients with stenosis or occlusions originating in the SFA
- up to 25 cm length of stenosis/occlusion
Key exclusion criteria (8 listed)
- previous bypass surgery at the site of treatment
- history of intolerance of anti-platelet therapy
- 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 |
|---|---|---|
| Nitinol stentInterventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram. | Device | 1, 2 |
| Nitinol Stent PlacementAlso: Product: peripheral stent system, Type: ASTRON, EC class: IIb, Certificate number: G1 01 10 10275 193Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions | Procedure or surgery | 1 |
Primary outcome
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
Time frame: 3, 6, 12 months
1 secondary outcome
ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure
Time frame: 3, 6, 12 months
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 15 Jul 2008.
- Background: PubMed 16672699Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
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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.
Martin Schilliger, Prof principal investigator
General Hospital of Vienna, Department of Angiology
Martin Schillinger, Prof principal investigator
General Hospital of Vienna
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 Nitinol stent and Nitinol Stent Placement in people with Peripheral Vascular Diseases and Intermittent Claudication, run by Vienna General Hospital at 1 site in Austria.
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 3 inclusion and 8 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 15 Jul 2008. 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 Austria. 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 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?
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). (time frame: 3, 6, 12 months). 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 NCT00715416, 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 15 Jul 2008.