Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent (SUMMIT)

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Provascular GmbH
ClinicalTrials.gov Identifier:
NCT01336101
First received: April 12, 2011
Last updated: February 11, 2013
Last verified: February 2013

April 12, 2011
February 11, 2013
April 2011
September 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Same as current
Complete list of historical versions of study NCT01336101 on ClinicalTrials.gov Archive Site
Technical Success [ Time Frame: after stent placement intra-procedural via angiographic images (day 1) ] [ Designated as safety issue: Yes ]
defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%.
Same as current
Not Provided
Not Provided
 
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral Arterial Diseases
  • Superficial Femoral Artery Stenosis
Device: EPIC™ Self-Expanding Nitinol Vascular Stent
SFA/Popliteal Artery stenting
Other Name: EPIC™ Self-Expanding Nitinol Vascular Stent
SFA stenting
Intervention: Device: EPIC™ Self-Expanding Nitinol Vascular Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2012
September 2012   (final data collection date for primary outcome measure)

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 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
  • 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

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(s).
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01336101
Prov 01 - 2011, ISROTH10001, U1111-1121-6816
Yes
Provascular GmbH
Provascular GmbH
Boston Scientific Corporation
Principal Investigator: Dierk Scheinert Park-Krankenhaus Leipzig
Provascular GmbH
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP