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SAMBA EU Femoropopliteal Trial

Primary Purpose

Peripheral Vascular Disease

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Stenting of atherosclerotic lesion(s)

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Peripheral vascular disease - SFA and popliteal arteries.

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Screening

Patient must be ≥ 21 years of age with life expectancy > 1 year.
Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain).
Patient must be a suitable candidate for PTA and stenting.
Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements.
The patient or legal representative has provided written informed consent using a form that is reviewed and approved by the EC for the Clinical Site.

Pre-Intervention

Target lesion has ≥ 50% stenosis as demonstrated angiographically.
Lesion length ≤ 15 cm.
Reference vessel diameter of 5 to 6 mm.
Patient has at least 1 vessel run-off prior to treatment.

Exclusion Criteria:

Screening

The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (Pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.)
Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure.
Subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the SAMBA Stent.
Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy.
Contrast allergy that cannot be corrected with medication (e.g. steroids, etc.).
Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment.
Patient is currently participating in another investigational drug or device study.

Pre-Intervention

Uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%).
Uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%)
Patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of SAMBA Stent(s).
Lack of 1 cm of healthy vessel proximal to proximal target
Lack of popliteal reconstitution (at least 2 cm of normal distal popliteal).
Inability to cross the lesion with a guidewire.
More than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting.
Unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).

Sites / Locations

Herz Zentrum Bad Krozingen
Herz-Zentrum Leipzig

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stent placement

Arm Description

Outcomes

Primary Outcome Measures

The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization.

The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio ≤ 2.5).

Secondary Outcome Measures

Clinically-Driven Target Lesion Revascularization (i.e., with documented preintervention evidence of at least 50% diameter stenosis (quantitative angiographic ≥ 50% or PSVR > 2.5).

Change in Rutherford Classification compared to pre-implant.

Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio ≤ 2.5).

Stent Fractures.

Full Information

NCT ID

NCT01139177

First Posted

June 4, 2010

Last Updated

June 7, 2010

Sponsor

NovoStent Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01139177

Brief Title

SAMBA EU Femoropopliteal Trial

Official Title

SAMBA EU Femoropopliteal Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

NovoStent Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and performance of the SAMBA Stent and Delivery System in the treatment of femoropopliteal lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

Keywords

Peripheral vascular disease - SFA and popliteal arteries.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stent placement

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Stenting of atherosclerotic lesion(s)

Other Intervention Name(s)

SAMBA Stent and Delivery System

Intervention Description

Stenting of atherosclerotic lesions post pre-dilatation of lesion(s)

Primary Outcome Measure Information:

Title

The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization.

Time Frame

through 30 days

Title

The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio ≤ 2.5).

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Clinically-Driven Target Lesion Revascularization (i.e., with documented preintervention evidence of at least 50% diameter stenosis (quantitative angiographic ≥ 50% or PSVR > 2.5).

Time Frame

12 months

Title

Change in Rutherford Classification compared to pre-implant.

Time Frame

12 months

Title

Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio ≤ 2.5).

Time Frame

12 months

Title

Stent Fractures.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Screening Patient must be ≥ 21 years of age with life expectancy > 1 year. Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain). Patient must be a suitable candidate for PTA and stenting. Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements. The patient or legal representative has provided written informed consent using a form that is reviewed and approved by the EC for the Clinical Site. Pre-Intervention Target lesion has ≥ 50% stenosis as demonstrated angiographically. Lesion length ≤ 15 cm. Reference vessel diameter of 5 to 6 mm. Patient has at least 1 vessel run-off prior to treatment. Exclusion Criteria: Screening The subject is pregnant or will become pregnant during the study or has any other condition that would preclude having x-rays. (Pre-menopausal women must have a negative pregnancy test within 7 days of the procedure.) Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure. Subject has had or plans to have a surgical or interventional procedure within 30 days before or after the implantation procedure of the SAMBA Stent. Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy. Contrast allergy that cannot be corrected with medication (e.g. steroids, etc.). Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment. Patient is currently participating in another investigational drug or device study. Pre-Intervention Uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%). Uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%) Patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of SAMBA Stent(s). Lack of 1 cm of healthy vessel proximal to proximal target Lack of popliteal reconstitution (at least 2 cm of normal distal popliteal). Inability to cross the lesion with a guidewire. More than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting. Unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dierk Scheinert, MD

Organizational Affiliation

Herz-Zentrum Leipzig

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herz Zentrum Bad Krozingen

City

Bad Krozingen

ZIP/Postal Code

D 79189

Country

Germany

Facility Name

Herz-Zentrum Leipzig

City

Leipzig

ZIP/Postal Code

D-04289

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

SAMBA EU Femoropopliteal Trial

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