Peripheral Artery DiseaseSTRONGNCT01154751
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
A study testing SUPERA Interwoven self-expanding nitinol stent in people with Peripheral Artery Disease and Femoropopliteal Artery Stenosis, run by Abbott Medical Devices at 4 sites in Germany.
Trial summary
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
- What is being tested?
- SUPERA Interwoven self-expanding nitinol stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2008to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- (Clinical)
- Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
- Rutherford-Becker classification 2 through 5 only
- Patient is at least 18 years of age and of legal age of consent.
- Patient must be willing to participate in the registry for at least 5 years.
- (Angiographic)
Show all 23Show fewer
- Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
- All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
- All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
- Target lesion length 1-20 cm (visual estimate)
- Target lesion stenosis ≥50% (visual estimate)
- Popliteal artery patent if the lesion is in the SFA
- SFA patent if the lesion is in the popliteal artery
- At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
- (Clinical)
- Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
- Patient is participating in a clinical study that could confound results
- Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
- (Angiographic)
- Target lesion length > 20 cm
- Instent restenotic / reoccluded target lesion
- Acute (≤ 4 weeks) thrombotic occlusion
- Untreated ipsilateral pelvic stenosis
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herzzentrum Abteilung fur Angiologie
Bad Krozingen, 79189
Heart Center Leipzig/Park Hospital
Leipzig, 04289
Kathlisches Klinikum Mainz
Mainz, 55131
Zentrum fur Diabetes-und GefaBerkrankungen
Münster, 48145
About this study
Official title: Supera Treatment Registry Observing Neointimal Growth
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
Read the detailed description
This registry follows up to 200 patients for at least 5 years.
The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
- Being tested
- SUPERA Interwoven self-expanding nitinol stent
- Keywords
- Femoral artery stenosis, Peripheral vascular Disease
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPERA Interwoven self-expanding nitinol stentDevice
Insertion of stent at stenotic area
| Study group | Role | What they receive |
|---|---|---|
| Device SUPERA Stent | Other | SUPERA Interwoven Self-Expanding Nitinol Stent System Receives: Device: SUPERA Interwoven self-expanding nitinol stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Measured: At baseline
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Measured: 30 days
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Measured: 6 months
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Measured: 1 Year
Secondary outcomes (16)
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Measured: 30 days
Number of Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Measured: 30 days
Rutherford-Becker Clinical Category
Rutherford/Becker Categories:
0 - Asymptomatic, no hemodynamically significant occlusive disease.
- - Mild claudication.
- - Moderate claudication.
- - Severe claudication.
- - Ischemic rest pain.
- - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
- - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Measured: 30 days
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Measured: 6 months
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Measured: 1 Year
Target Lesion Revascularization
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Measured: 6 months
Target Lesion Revascularization
Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)
Measured: 1 Year
Stent Fracture
Stent fractures determined by fluoroscopy .
Measured: 1 Year
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Measured: 1 to 2 years
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Measured: 1 to 3 Years
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Measured: At baseline
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Measured: 30 days
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Measured: 6 months
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Measured: 1 Year
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Measured: 2 Years
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startNov 2008
- Primary completionAug 2012
- Study completionAug 2015
Why it stopped: Slow enrollment,increased loss to follow-ups and general lack of interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof Dr med, Principal investigator, Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154751
- Sponsor's protocol ID
- IDEV Technologies, Inc.
- Acronym
- STRONG
- Status last verified
- Aug 2017
- First submitted
- 29 Jun 2010
- Last updated
- 19 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supera Treatment Registry Observing Neointimal Growth
- ClinicalTrials.gov ID
- NCT01154751
- Acronym / sponsor ID
- STRONG / IDEV Technologies, Inc.
- Keywords
- Femoral artery stenosis, Peripheral vascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment,increased loss to follow-ups and general lack of interest.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
Detailed description
This registry follows up to 200 patients for at least 5 years.
The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device SUPERA Stent | Other | Device: SUPERA Interwoven self-expanding nitinol stentSUPERA Interwoven Self-Expanding Nitinol Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- (Clinical)
- Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
- Rutherford-Becker classification 2 through 5 only
- Patient is at least 18 years of age and of legal age of consent.
- Patient must be willing to participate in the registry for at least 5 years.
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 |
|---|---|---|
| SUPERA Interwoven self-expanding nitinol stentInsertion of stent at stenotic area | Device | Device SUPERA Stent |
Primary outcome
Six-minute Walking Distance
Time frame: At baseline
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
Time frame: 30 days
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
Time frame: 6 months
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
Time frame: 1 Year
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
16 secondary outcomes
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
Time frame: 30 days
Number of Peri-procedural and Post-procedural Complications
Time frame: 30 days
Rutherford-Becker Clinical Category
Time frame: 30 days
Restenosis by Duplex Ultrasound
Time frame: 6 months
Restenosis by Duplex Ultrasound
Time frame: 1 Year
Target Lesion Revascularization
Time frame: 6 months
Target Lesion Revascularization
Time frame: 1 Year
Stent Fracture
Time frame: 1 Year
Stent Fracture
Time frame: 1 to 2 years
Stent Fracture
Time frame: 1 to 3 Years
Target Limb Ankle Brachial Index (at Rest)
Time frame: At baseline
Target Limb Ankle Brachial Index (at Rest)
Time frame: 30 days
Target Limb Ankle Brachial Index (at Rest)
Time frame: 6 months
Target Limb Ankle Brachial Index (at Rest)
Time frame: 1 Year
Target Limb Ankle Brachial Index (at Rest)
Time frame: 2 Years
Six-minute Walking Distance
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Zeller, Prof Dr med principal investigator
Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPERA Interwoven self-expanding nitinol stent in people with Peripheral Artery Disease and Femoropopliteal Artery Stenosis, run by Abbott Medical Devices at 4 sites 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 0 inclusion and 23 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Six-minute Walking Distance (time frame: At baseline). The study lists 4 primary outcomes in all. 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 19 Sep 2017.