search
Back to results

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

Primary Purpose

Peripheral Arterial Diseases, Superficial Femoral Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EPIC™ Self-Expanding Nitinol Vascular Stent
Sponsored by
Provascular GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Diseases focused on measuring PAD, SFA

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Herz-Zentrum
  • Weisseritztal-Kliniken
  • Park-Krankenhaus
  • Medinos Kliniken

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SFA stenting

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Technical Success
defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%.

Full Information

First Posted
April 12, 2011
Last Updated
April 23, 2014
Sponsor
Provascular GmbH
Collaborators
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01336101
Brief Title
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
Acronym
SUMMIT
Official Title
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Provascular GmbH
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Diseases, Superficial Femoral Artery Stenosis
Keywords
PAD, SFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFA stenting
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
EPIC™ Self-Expanding Nitinol Vascular Stent
Intervention Description
SFA/Popliteal Artery stenting
Primary Outcome Measure Information:
Title
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Description
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Time Frame
at 6 months after procedure
Title
efficacy of the EPIC™ Stent as measured by the in-stent binary restenosis using duplex ultrasound (DUS)
Description
Binary restenosis is defined as a peak systolic velocity ratio (PSVR) ≥2.5:1.
Time Frame
at 12 months after procedure
Secondary Outcome Measure Information:
Title
Technical Success
Description
defined as the ability to implant the stent with a residual angiographic stenosis no greater than 30%.
Time Frame
after stent placement intra-procedural via angiographic images (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert
Organizational Affiliation
Park-Krankenhaus Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz-Zentrum
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Weisseritztal-Kliniken
City
Freital
ZIP/Postal Code
01405
Country
Germany
Facility Name
Park-Krankenhaus
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Medinos Kliniken
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24325691
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs