Peripheral Arterial DiseasesSUMMITNCT01336101
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
A study testing EPIC™ Self-Expanding Nitinol Vascular Stent in people with Peripheral Arterial Diseases and Superficial Femoral Artery Stenosis, run by Provascular GmbH at 4 sites in Germany.
Trial summary
The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease. 100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Diseases, Superficial Femoral Artery Stenosis
- What is being tested?
- EPIC™ Self-Expanding Nitinol Vascular Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2011to Nov 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects, male or female, must be between the ages of 18 to 85 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
- Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
- Rutherford Classification Category 2-4
- Single de novo lesion in the superficial femoro/popliteal artery
- Disease segment length ≤150mm
- >70% diameter stenosis and occlusion
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- Patent ipsilateral iliac artery
- Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
- Target reference vessel diameter 3.5-7.5 mm
Who cannot join
- Target lesion previously treated with a stent or surgery.
- Rutherford Classification Category 0, 1, 5 or 6.
- Inability to tolerate antithrombotic or antiplatelet therapies.
- Pregnancy.
- Other co morbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
- Serum creatinine > 2.5 mg/dL.
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- Myocardial infarction or stroke within 90 days of enrollment.
- Hypercoagulable state.
- Uncontrollable hypertension.
- Patients currently enrolled in any other clinical trial(s).
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herz-Zentrum
Bad Krozingen, 79189
Weisseritztal-Kliniken
Freital, 01405
Park-Krankenhaus
Leipzig, 04289
Medinos Kliniken
Sonneberg, 96515
About this study
Official title: Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry
The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease.
100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months.
Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
Read the detailed description
The SUMMIT Registry addresses the treatment of peripheral arterial disease (PAD).
PAD represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These vessels are exposed to enormous mechanical stress what represents a harsh environment for any endovascular device. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries.
Subject of study is the EPIC™ Femoropopliteal Self-Expanding Stent System which provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel.
Primary objective is to evaluate the efficacy of the device in treating lesions of the SFA/Popliteal artery.
The project is a multi-centre open label study. Primary efficacy parameter will be assessed by measuring the in-stent binary stenosis using duplex ultrasound at 6 and 12 months after the stent placement. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Anticipated study duration is 18 months: 6 months recruiting and 12 months follow-up.
- Being tested
- EPIC™ Self-Expanding Nitinol Vascular Stent
- Keywords
- PAD, SFA
- 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.
EPIC™ Self-Expanding Nitinol Vascular StentDevice
SFA/Popliteal Artery stenting
| Study group | Role | What they receive |
|---|---|---|
| SFA stenting | Other | Not described Receives: Device: EPIC™ Self-Expanding Nitinol Vascular Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Measured: at 6 months after procedure
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Measured: at 12 months after procedure
Secondary outcomes (1)
Technical Success
defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%.
Measured: after stent placement intra-procedural via angiographic images (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionNov 2012
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provascular GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, Principal investigator, Park-Krankenhaus Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336101
- Sponsor's protocol ID
- Prov 01 - 2011
- Other IDs
- ISROTH10001, U1111-1121-6816
- Acronym
- SUMMIT
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2011
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Werner M, Piorkowski M, Thieme M, Nanning T, Beschorner U, Rastan A, Zeller T, Scheinert D. SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment. J Endovasc Ther. 2013 Dec;20(6):759-66. doi: 10.1583/13-4430R.1.
PubMed 24325691
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry
- ClinicalTrials.gov ID
- NCT01336101
- Acronym / sponsor ID
- SUMMIT / Prov 01 - 2011
- Keywords
- PAD, SFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Provascular GmbHUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Apr 2011 (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 intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease.
100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months.
Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
Detailed description
The SUMMIT Registry addresses the treatment of peripheral arterial disease (PAD).
PAD represents a major challenge to physicians in treating the Superficial Femoral (SFA) and Popliteal arteries. These vessels are exposed to enormous mechanical stress what represents a harsh environment for any endovascular device. During flexing of the knee, the SFA/Popliteal arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for use in the SFA/Popliteal arteries would offer great ranges of movement while adequately supporting the arteries.
Subject of study is the EPIC™ Femoropopliteal Self-Expanding Stent System which provides a great range of motions for a highly flexible femoral artery while adequately supporting the vessel.
Primary objective is to evaluate the efficacy of the device in treating lesions of the SFA/Popliteal artery.
The project is a multi-centre open label study. Primary efficacy parameter will be assessed by measuring the in-stent binary stenosis using duplex ultrasound at 6 and 12 months after the stent placement. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Anticipated study duration is 18 months: 6 months recruiting and 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SFA stenting | Other | Device: EPIC™ Self-Expanding Nitinol Vascular Stent |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects, male or female, must be between the ages of 18 to 85 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
- Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
- Rutherford Classification Category 2-4
- Single de novo lesion in the superficial femoro/popliteal artery
- Disease segment length ≤150mm
Key exclusion criteria (10 listed)
- Target lesion previously treated with a stent or surgery.
- Rutherford Classification Category 0, 1, 5 or 6.
- Inability to tolerate antithrombotic or antiplatelet therapies.
- Pregnancy.
- Other co morbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
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 |
|---|---|---|
| EPIC™ Self-Expanding Nitinol Vascular StentSFA/Popliteal Artery stenting | Device | SFA stenting |
Primary outcome
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Time frame: at 6 months after procedure
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Time frame: at 12 months after procedure
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
1 secondary outcome
Technical Success
Time frame: after stent placement intra-procedural via angiographic images (day 1)
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 24 Apr 2014.
- Derived from this study: PubMed 24325691Werner M, Piorkowski M, Thieme M, Nanning T, Beschorner U, Rastan A, Zeller T, Scheinert D. SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment. J Endovasc Ther. 2013 Dec;20(6):759-66. doi: 10.1583/13-4430R.1.
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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.
Dierk Scheinert principal investigator
Park-Krankenhaus Leipzig
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIC™ Self-Expanding Nitinol Vascular Stent in people with Peripheral Arterial Diseases and Superficial Femoral Artery Stenosis, run by Provascular GmbH 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 9 inclusion and 10 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 24 Apr 2014. 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?
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?
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS) (time frame: at 6 months after procedure). The study lists 2 primary outcomes in all. 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 NCT01336101, 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 24 Apr 2014.