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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
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Arterial Diseases
Superficial Femoral Artery Stenosis
 Device: EPIC™ Self-Expanding Nitinol Vascular Stent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Provascular GmbH:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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%.


Enrollment: 100
Study Start Date: April 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SFA stenting Device: EPIC™ Self-Expanding Nitinol Vascular Stent
SFA/Popliteal Artery stenting
Other Name: EPIC™ Self-Expanding Nitinol Vascular Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336101

Locations
Germany
Herz-Zentrum
Bad Krozingen, Germany, 79189
Weisseritztal-Kliniken
Freital, Germany, 01405
Park-Krankenhaus
Leipzig, Germany, 04289
Medinos Kliniken
Sonneberg, Germany, 96515
Sponsors and Collaborators
Provascular GmbH
Boston Scientific Corporation
Investigators
Principal Investigator: Dierk Scheinert Park-Krankenhaus Leipzig
  More Information

No publications provided

Responsible Party: Provascular GmbH
ClinicalTrials.gov Identifier: NCT01336101     History of Changes
Other Study ID Numbers: Prov 01 - 2011, ISROTH10001, U1111-1121-6816
Study First Received: April 12, 2011
Last Updated: February 11, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Provascular GmbH:
PAD
SFA

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013