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

NCT01336101 | Completed DMC

• 3 other identifiers: Prov 01 - 2011ISROTH10001U1111-1121-6816
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Diseases; Superficial Femoral Artery Stenosis

Keywords

PAD; SFA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Technical Success

  after stent placement intra-procedural via angiographic images (day 1)

Study Arms (1)

SFA stenting

OTHER

Device: EPIC™ Self-Expanding Nitinol Vascular Stent

Interventions

EPIC™ Self-Expanding Nitinol Vascular Stent DEVICE

SFA/Popliteal Artery stenting

SFA stenting

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Provascular GmbH: lead
• Boston Scientific Corporation: collaborator

Study Sites (4)

Herz-Zentrum

Bad Krozingen, 79189, Germany

Location

Weisseritztal-Kliniken

Freital, 01405, Germany

Location

Park-Krankenhaus

Leipzig, 04289, Germany

Location

Medinos Kliniken

Sonneberg, 96515, Germany

Location

Related Publications (1)

• 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.

  PMID: 24325691 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Dierk Scheinert

  Park-Krankenhaus Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

DE (4)