SAMBA EU Femoropopliteal Trial

Peripheral Vascular Disease Clinical Trial

Official title:

SAMBA EU Femoropopliteal Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01139177
• Other study ID #: 60-00857-01
• Status: Active, not recruiting
• Phase: N/A
• First received: June 4, 2010
• Last updated: June 7, 2010
• Start date: April 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2010
• Source: NovoStent Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Screening

1. Patient must be = 21 years of age with life expectancy > 1 year.

2. Symptomatic leg ischemia requiring treatment of the superficial femoral and/or popliteal artery (Rutherford category 2-4; claudication, rest pain).

3. Patient must be a suitable candidate for PTA and stenting.

4. Patient is willing and able to return to the site of the investigation at the specified study intervals and undergo follow-up requirements.

5. 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

1. Target lesion has = 50% stenosis as demonstrated angiographically.

2. Lesion length = 15 cm.

3. Reference vessel diameter of 5 to 6 mm.

4. Patient has at least 1 vessel run-off prior to treatment.

Exclusion Criteria:

Screening

1. 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.)

2. Patients who have experienced a cardiovascular accident (CVA) or a myocardial infarction (MI) within 3 months prior to the procedure.

3. 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.

4. Existing hemorrhagic disease or coagulation problems or inability to take dual anti-platelet therapy.

5. Contrast allergy that cannot be corrected with medication (e.g. steroids, etc.).

6. 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.

7. Patient is currently participating in another investigational drug or device study.

Pre-Intervention

1. Uncorrectable severe aorto-iliac occlusive disease or severe common femoral artery stenosis preventing access or limiting inflow (e.g., stenosis greater than 50%).

2. Uncorrectable occlusive disease limiting outflow (e.g., stenosis greater than 50%)

3. Patients with previous surgery in the target vessel or stent that will be closer than 2 cm to either edge of SAMBA Stent(s).

4. Lack of 1 cm of healthy vessel proximal to proximal target

5. Lack of popliteal reconstitution (at least 2 cm of normal distal popliteal).

6. Inability to cross the lesion with a guidewire.

7. More than 1 lesion in the same limb requiring treatment that will not be covered by continuous stenting.

8. Unsuccessful balloon pre-dilation (i.e., the residual stenosis is greater than 30%).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Herz Zentrum Bad Krozingen	Bad Krozingen
Germany	Herz-Zentrum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
NovoStent Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoint is defined as freedom from all cause death, unplanned index limb amputation, and target lesion revascularization.		through 30 days	Yes
Primary	The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio = 2.5).		3 months	No
Secondary	Clinically-Driven Target Lesion Revascularization (i.e., with documented preintervention evidence of at least 50% diameter stenosis (quantitative angiographic = 50% or PSVR > 2.5).		12 months	No
Secondary	Change in Rutherford Classification compared to pre-implant.		12 months	No
Secondary	Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio = 2.5).		12 months	No
Secondary	Stent Fractures.		12 months	No