Trial document




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  DRKS00003090

Trial Description

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Title

The SUMMIT -Registry

Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System

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Trial Acronym

SUMMIT

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URL of the Trial

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Brief Summary in Lay Language

One way to treat the peripheral artery disease (PAD) is stent placement.
The SUMMIT-Registry is conducted to evaluate the treatment of arterial occlusions in femoral/knee vessels.

subject of study in particular is the evaluation of efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent. This stent has been designed specifically to fullfill the extreme requirements of the femoral and knee artery.
Study population: 100 subjects.

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Brief Summary in Scientific Language

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.


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Organizational Data

  •   DRKS00003090
  •   2011/05/25
  •   2011/04/14
  •   no
  •   Approved
  •   021-11-24012011, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1121-6816 
  •   NCT01336101  (Clinical Trials)
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Health Condition or Problem studied

  •   I73.9 -  Peripheral vascular disease, unspecified
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Interventions/Observational Groups

  •   femoropopliteal lesions - stent placement as follows:

    - standard medication for SFA/Popliteal Artery stenting according to hospital standard (Lifelong aspirin 75-100mg/day commencing at least day before procedure, Clopidogrel loading dose of 300mg day before procedure, 75mg day of procedure and 75mg/day for 1 month post-procedure, Heparin intra-procedurally to maintain ACT ≥ 250s )

    - Procedural techniques identically to routine protocols for SFA/Popliteal Artery stenting at respective hospital with following suggestions: Continuous monitoring of pulse oximetry and blood pressure, Contralateral retrograde common femoral cross-over access or antegrade access (retrograde popliteal or transpedal access not allowed within this registry), Non-ionic iodinated contrast, Target lower limb arteries fully imaged angiographically, pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis, Deployment of EPIC™Stent to cover target lesion, Post-stent balloon dilate stent, post stenting angiography
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

efficacy of the EPIC™ Stent as measured by in-stent binary restenosis using DUS at 6 and 12 months after procedure
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1

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Secondary Outcome

technical success defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%
after stent placement intra-procedural via angiographic images

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/04/12
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

- 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
- Rutherford Classification Category 2-4
- Single de novo lesion in the superficial femoro/popliteal artery
- Disease segment length ≤150mm
->70% diameter stenosis and occlusion
- 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

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Exclusion Criteria

- 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
- Myocardial infarction or stroke within 90 days of enrollment
Hypercoagulable state
- Uncontrollable hypertension
- Patients currently enrolled in any other clinical trial

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Addresses

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    • Provascular GmbH
    • Mr.  Dr.  Dominik  Hornung 
    • Sonnenleite 3
    • 91336   Heroldsbach
    • Germany
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    • Provascular GmbH
    • Mr.  Dr.  Dominik  Hornung 
    • Sonnenleite 3
    • 91336   Heroldsbach
    • Germany
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    • Provascular GmbH
    • Ms.  Janine  Lieschke 
    • Paul-List-Straße 11
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Boston Scientific
    • MN55112  St Paul
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/13
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Trial Publications, Results and other Documents

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