AtherosclerosisSTRIDESNCT00475566
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
A study testing Dynalink®-E everolimus-eluting peripheral stent and Dynalink®-E, everolimus-eluting peripheral stent in people with Atherosclerosis and Peripheral Vascular Disease, run by Abbott Medical Devices at 10 sites in 4 countries.
Trial summary
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Peripheral Vascular Disease
- What is being tested?
- Dynalink®-E everolimus-eluting peripheral stent and Dynalink®-E, everolimus-eluting peripheral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 10 sitesin 4 countries
- Study dates
- May 2007to Feb 2010
- Phase
- Interventional
- 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
- Rutherford Becker Category 2-5
- Single de novo or restenotic lesion in the superficial femoral or proximal popliteal artery
- Disease segment length 30-170 mm
- >50% diameter stenosis or total occlusion
- Target reference vessel diameter 4.3-7.3 mm
Who cannot join
- Target lesion previously treated with stent or surgery
- Rutherford Becker Category 0, 1, or 6
- Immunosuppressive disorder or currently receiving immunosuppressive agents
- Serum creatinine >2.5 mg/dl
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany4 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
The Jewish Hospital Berlin
Berlin, 13347
Herzzentrum Leipzig
Leipzig, 04289
University Hospital Tübingen
Tübingen, 72076
Belgium3 sites
Sint Blasius Hospital
Dendermonde
ZOL St. Jan
Ghent, 3600
University Hospital
Ghent, 9000
Austria2 sites
Landeskrankenhaus Klagenfurt
Klagenfurt, 9020
Allgemeines Krankenhaus der Stadt Wien- AKH Wien
Vienna, 1090
About this study
Official title: A Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for Treating Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions
The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions.
Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The decision to discontinue the study is not related to any safety concern. The rationale for this proposal is based on the following considerations:
Read more
The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure.
Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E.
Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue.
The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.
Read the detailed description
A prospective, Non-Randomized, Single-arm, Multi-center, Clinical Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for the Treatment of Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions.
- Conditions
- Atherosclerosis, Peripheral Vascular Disease
- Being tested
- Dynalink®-E everolimus-eluting peripheral stent, Dynalink®-E, everolimus-eluting peripheral stent
- Medical subject headings
- Atherosclerosis, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynalink®-E everolimus-eluting peripheral stentDevice
Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
Dynalink®-E, everolimus-eluting peripheral stentDevice
Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | This is a prospective, non-randomized, single-arm, multi-center study. A projected 100 patients will receive the stent(s) in this study at approximately 10-15 European sites. The primary objective is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral or proximal popliteal lesions. Receives: Device: Dynalink®-E everolimus-eluting peripheral stent; Device: Dynalink®-E, everolimus-eluting peripheral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound
Measured: 6 months
Secondary outcomes (3)
Angiographic in-stent binary restenosis rate (>50%)
Measured: 12 months
Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis
Measured: 12 months
Primary, and secondary patency
Measured: 1, 6, 12, 18 months, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionJul 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Lammer, M.D., Principal investigator, Allgemeines Krankenhaus der Stadt Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475566
- Sponsor's protocol ID
- 06-103
- Acronym
- STRIDES
- Status last verified
- Mar 2011
- First submitted
- 16 May 2007
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lammer J, Scheinert D, Vermassen F, Koppensteiner R, Hausegger KA, Schroe H, Menon RM, Schwartz LB. Pharmacokinetic analysis after implantation of everolimus-eluting self-expanding stents in the peripheral vasculature. J Vasc Surg. 2012 Feb;55(2):400-5. doi: 10.1016/j.jvs.2011.08.048. Epub 2011 Nov 1.
PubMed 22051872Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 12.
PubMed 21658885
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for Treating Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions
- ClinicalTrials.gov ID
- NCT00475566
- Acronym / sponsor ID
- STRIDES / 06-103
- Conditions
- Atherosclerosis, Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 May 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 first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions.
Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The decision to discontinue the study is not related to any safety concern. The rationale for this proposal is based on the following considerations:
The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure.
Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E.
Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue.
The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.
Detailed description
A prospective, Non-Randomized, Single-arm, Multi-center, Clinical Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for the Treatment of Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Dynalink®-E everolimus-eluting peripheral stent, Device: Dynalink®-E, everolimus-eluting peripheral stentThis is a prospective, non-randomized, single-arm, multi-center study. A projected 100 patients will receive the stent(s) in this study at approximately 10-15 European sites. The primary objective is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral or proximal popliteal lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rutherford Becker Category 2-5
- Single de novo or restenotic lesion in the superficial femoral or proximal popliteal artery
- Disease segment length 30-170 mm
- >50% diameter stenosis or total occlusion
- Target reference vessel diameter 4.3-7.3 mm
Key exclusion criteria (4 listed)
- Target lesion previously treated with stent or surgery
- Rutherford Becker Category 0, 1, or 6
- Immunosuppressive disorder or currently receiving immunosuppressive agents
- Serum 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 |
|---|---|---|
| Dynalink®-E everolimus-eluting peripheral stentStenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery | Device | 1 |
| Dynalink®-E, everolimus-eluting peripheral stentStenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery | Device | 1 |
Primary outcome
In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound
Time frame: 6 months
3 secondary outcomes
Angiographic in-stent binary restenosis rate (>50%)
Time frame: 12 months
Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis
Time frame: 12 months
Primary, and secondary patency
Time frame: 1, 6, 12, 18 months, 2, 3, 4, 5 years
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 10 Mar 2011.
- Derived from this study: PubMed 22051872Lammer J, Scheinert D, Vermassen F, Koppensteiner R, Hausegger KA, Schroe H, Menon RM, Schwartz LB. Pharmacokinetic analysis after implantation of everolimus-eluting self-expanding stents in the peripheral vasculature. J Vasc Surg. 2012 Feb;55(2):400-5. doi: 10.1016/j.jvs.2011.08.048. Epub 2011 Nov 1.
- Derived from this study: PubMed 21658885Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 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.
Johannes Lammer, M.D. principal investigator
Allgemeines Krankenhaus der Stadt Wien
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynalink®-E everolimus-eluting peripheral stent and Dynalink®-E, everolimus-eluting peripheral stent in people with Atherosclerosis and Peripheral Vascular Disease, run by Abbott Medical Devices at 10 sites in 4 countries.
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 5 inclusion and 4 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 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, Austria, Italy. 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.
What does the primary outcome measure?
In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound (time frame: 6 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 NCT00475566, which also lists 2 linked publications.
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 10 Mar 2011.