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

NCT00180505 | Completed Phase 4

• 1 other identifier: 04-100
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 13

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.

Conditions

Peripheral Vascular Diseases

Keywords

Peripheral Artery Disease; Restenosis Rate; Patency Rates; Self-Expandable Nitinol Stents; Stent Fractures

Outcome Measures

Primary Outcomes (1)

• Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).

  At 180 days

Secondary Outcomes (8)

• 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

Study Arms (1)

1

OTHER

The purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.

Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent

Interventions

ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent DEVICE

A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.

1

Eligibility Criteria

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

You may qualify if:

• De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
• mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

Landeskrankenhaus Klagenfurt

Klagenfurt, 9026, Austria

Location

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, 1090, Austria

Location

CHR de Namur

Namur, 5000, Belgium

Location

Polyclinique Louis Pasteur

Essey-lès-Nancy, 54270, France

Location

Hôpital Pontchaillou- CHU

Rennes, 35033, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitäres Herz & Gefässzentrum Hamburg

Hamburg, 22527, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Papageorgiou Hospital

Thessaloniki, 57001, Greece

Location

Nuovo Ospedale Civile Sant' Agostino

Baggiovara (Modena), 41100, Italy

Location

Casa di Cura Montevergine

Mercogliano, 83013, Italy

Location

Policlinico San Matteo

Pavia, 27100, Italy

Location

Hospital de Donostia

Donostia / San Sebastian, 20014, Spain

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Thomas Zeller, M.D.

  Herzzentrum Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: October 1, 2009
• Last Updated: February 24, 2010

Record last verified: 2010-02

Locations

AU (2); GR (1); FR (2); IT (3); ES (1); DE (3); BE (1)