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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


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
See also
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Completed NCT01327950 - Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions N/A
Completed NCT05451485 - VFI in Healthy Vessels
Not yet recruiting NCT04175197 - LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
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Completed NCT01602159 - Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST) N/A
Not yet recruiting NCT06410313 - First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease N/A
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Recruiting NCT05132361 - SELUTION4SFA Trial N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A