Clinical trial NCT00180505: ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
Official title: Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vascular Diseases
Keywords: Peripheral Artery Disease
Restenosis Rate
Patency Rates
Self-Expandable Nitinol Stents
Stent Fractures
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 proximal popliteal arteries.

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 (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).

Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).
timeFrame: At 180 days
Secondary outcomes:
measure: Clinically driven target lesion revascularization
timeFrame: at 12 and 24 month follow-up
measure: Target lesion primary, primary assisted and secondary patency rates
timeFrame: at 6, 12 and 24 month follow-up
measure: Major complications
timeFrame: at 1, 6, 12 and 24 month follow-up
measure: Angiographic binary restenosis rate in a subset of patients
timeFrame: at 9 month follow-up
measure: Device and procedure success
timeFrame: Acute
measure: Vascular and bleeding complications (local and puncture site)
timeFrame: 1, 6, 12, 24 months
measure: Stent fracture determined by biplane X-ray
timeFrame: at 12 month follow-up
measure: Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound)
timeFrame: 365 days and 2 years
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
city: Namur
country: Belgium
facility: CHR de Namur
city: Essey les Nancy
country: France
facility: Polyclinique Louis Pasteur
city: Rennes Cedex
country: France
facility: Hôpital Pontchaillou- CHU
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Hamburg
country: Germany
facility: Universitäres Herz & Gefässzentrum Hamburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Thessaloniki
country: Greece
facility: Papageorgiou Hospital
city: Baggiovara (Modena)
country: Italy
facility: Nuovo Ospedale Civile Sant' Agostino
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Donostia-San Sebastian
country: Spain
facility: Hospital de Donostia
Study officials:
affiliation: Herzzentrum Bad Krozingen, Germany
name: Thomas Zeller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: