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

Phase 4

Completed

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT00180505
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-03
• Study Completion: 2009-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).	At 180 days

Secondary Outcome Measures

Name	Time	Method
Clinically driven target lesion revascularization	at 12 and 24 month follow-up
Target lesion primary, primary assisted and secondary patency rates	at 6, 12 and 24 month follow-up
Major complications	at 1, 6, 12 and 24 month follow-up
Angiographic binary restenosis rate in a subset of patients	at 9 month follow-up
Device and procedure success	Acute
Vascular and bleeding complications (local and puncture site)	1, 6, 12, 24 months
Stent fracture determined by biplane X-ray	at 12 month follow-up
Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound)	365 days and 2 years

Trial Locations

Locations (13)

CHR de Namur; 🇧🇪 Namur, Belgium

Universitäres Herz & Gefässzentrum Hamburg; 🇩🇪 Hamburg, Germany

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Hôpital Pontchaillou- CHU; 🇫🇷 Rennes Cedex, France

Polyclinique Louis Pasteur; 🇫🇷 Essey les Nancy, France

Hospital de Donostia; 🇪🇸 Donostia-San Sebastian, Spain

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Landeskrankenhaus Klagenfurt; 🇦🇹 Klagenfurt, Austria

Allgemeines Krankenhaus der Stadt Wien (AKH Wien); 🇦🇹 Wien, Austria

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Nuovo Ospedale Civile Sant' Agostino; 🇮🇹 Baggiovara (Modena), Italy

Casa di Cura Montevergine; 🇮🇹 Mercogliano, Italy

Papageorgiou Hospital; 🇬🇷 Thessaloniki, Greece