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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Diseases; Superficial Femoral Artery Stenosis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Herz-Zentrum
  • Freital, Germany, 01405
    • Weisseritztal-Kliniken
  • Leipzig, Germany, 04289
    • Park-Krankenhaus
  • Sonneberg, Germany, 96515
    • Medinos Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SFA stenting	Device: EPIC™ Self-Expanding Nitinol Vascular Stent; SFA/Popliteal Artery stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 12 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (day 1)

Collaborators and Investigators

• Sponsor: Provascular GmbH
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Dierk Scheinert, Park-Krankenhaus Leipzig

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 15, 2011

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: PAD; SFA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Prov 01 - 2011; ISROTH10001 (Other Grant/Funding Number: Boston Scientific); U1111-1121-6816 (Registry Identifier: Universal Trial Number)