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

Superficial Femoral Artery Stenosis Clinical Trial

— SUMMIT  

Official title:

Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent With Delivery System -The SUMMIT Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336101
• Other study ID #: Prov 01 - 2011
• Secondary ID: ISROTH10001U1111
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: April 23, 2014
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: Provascular GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases
• Superficial Femoral Artery Stenosis

Intervention

Device:
• EPIC™ Self-Expanding Nitinol Vascular Stent
SFA/Popliteal Artery stenting

Locations

Country	Name	City	State
Germany	Herz-Zentrum	Bad Krozingen
Germany	Weisseritztal-Kliniken	Freital
Germany	Park-Krankenhaus	Leipzig
Germany	Medinos Kliniken	Sonneberg

Sponsors (2)

Lead Sponsor	Collaborator
Provascular GmbH	Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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)	Yes