SAMBA EU Femoropopliteal Trial

NCT01139177 | Unknown

• 1 other identifier: 60-00857-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Vascular Disease

Keywords

Peripheral vascular disease - SFA and popliteal arteries.

Outcome Measures

Primary Outcomes (2)

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

  through 30 days

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

  3 months

Secondary Outcomes (4)

• 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

• Change in Rutherford Classification compared to pre-implant.

  12 months

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

  12 months

• Stent Fractures.

  12 months

Study Arms (1)

Stent placement

EXPERIMENTAL

Device: Stenting of atherosclerotic lesion(s)

Interventions

Stenting of atherosclerotic lesion(s) DEVICE

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

Also known as: SAMBA Stent and Delivery System

Stent placement

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovoStent Corporation: lead

Study Sites (2)

Herz Zentrum Bad Krozingen

Bad Krozingen, D 79189, Germany

Location

Herz-Zentrum Leipzig

Leipzig, D-04289, Germany

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dierk Scheinert, MD

  Herz-Zentrum Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: April 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2010-06

Locations

DE (2)