SAMBA EU Femoropopliteal Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by NovoStent Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NovoStent Corporation
ClinicalTrials.gov Identifier:
NCT01139177
First received: June 4, 2010
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Peripheral Vascular Disease
Device: Stenting of atherosclerotic lesion(s)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SAMBA EU Femoropopliteal Trial

Resource links provided by NLM:


Further study details as provided by NovoStent Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The primary efficacy endpoint is defined as stent patency via Color Duplex Ultrasound (Peak Velocity Ratio ≤ 2.5). [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in Rutherford Classification compared to pre-implant. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent Patency via Color Duplex Ultrasound (Peak Systolic Velocity Ratio ≤ 2.5). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent Fractures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: April 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent placement Device: Stenting of atherosclerotic lesion(s)
Stenting of atherosclerotic lesions post pre-dilatation of lesion(s)
Other Name: SAMBA Stent and Delivery System

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139177

Locations
Germany
Herz Zentrum Bad Krozingen
Bad Krozingen, Germany, D 79189
Herz-Zentrum Leipzig
Leipzig, Germany, D-04289
Sponsors and Collaborators
NovoStent Corporation
Investigators
Principal Investigator: Dierk Scheinert, MD Herz-Zentrum Leipzig
  More Information

No publications provided

Responsible Party: Earle Canty, VP RACAQA, NovoStent Corporation
ClinicalTrials.gov Identifier: NCT01139177     History of Changes
Other Study ID Numbers: 60-00857-01
Study First Received: June 4, 2010
Last Updated: June 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by NovoStent Corporation:
Peripheral vascular disease - SFA and popliteal arteries.

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 22, 2014