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Status:

COMPLETED

ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Lead Sponsor:

Abbott Medical Devices

Conditions:

Peripheral Vascular Diseases

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proxima...

Detailed Description

The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainl...

Eligibility Criteria

Inclusion

  • De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
  • 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and
  • 20 mm from the proximal margin of the intercondylar fossa.
  • Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel
  • Target vessel reference diameter visually estimated to be \> 4.0 mm and \< 7.0 mm
  • Target lesion length visually estimated to be \> 40 mm and \< 200 mm
  • If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator
  • At least one-vessel run-off to the foot confirmed by baseline angiography
  • Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of \< 30% without death, stroke, bleeding requiring \> 2 units transfusion, or any other complication which was device or procedure related.
  • Patient is acceptable candidate for femoral-popliteal artery bypass surgery

Exclusion

  • Previous ipsilateral femoro-popliteal or femoro-tibial surgery
  • Presence of a stent in the target vessel
  • Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure
  • Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries
  • Acute thrombophlebitis or deep vein thrombus
  • Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection
  • Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy
  • Hemodynamic instability
  • Target lesion is restenotic from previous intervention

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2009

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00180505

Start Date

March 1 2005

End Date

October 1 2009

Last Update

February 24 2010

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Landeskrankenhaus Klagenfurt

Klagenfurt, Austria, 9026

2

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, Austria, 1090

3

CHR de Namur

Namur, Belgium, 5000

4

Polyclinique Louis Pasteur

Essey-lès-Nancy, France, 54270