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

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00180505
First received: September 13, 2005
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound). [ Time Frame: At 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinically driven target lesion revascularization [ Time Frame: at 12 and 24 month follow-up ] [ Designated as safety issue: No ]
  • Target lesion primary, primary assisted and secondary patency rates [ Time Frame: at 6, 12 and 24 month follow-up ] [ Designated as safety issue: No ]
  • Major complications [ Time Frame: at 1, 6, 12 and 24 month follow-up ] [ Designated as safety issue: Yes ]
  • Angiographic binary restenosis rate in a subset of patients [ Time Frame: at 9 month follow-up ] [ Designated as safety issue: No ]
  • Device and procedure success [ Time Frame: Acute ] [ Designated as safety issue: No ]
  • Vascular and bleeding complications (local and puncture site) [ Time Frame: 1, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
  • Stent fracture determined by biplane X-ray [ Time Frame: at 12 month follow-up ] [ Designated as safety issue: No ]
  • Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound) [ Time Frame: 365 days and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2005
Study Completion Date: October 2009
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00180505

Locations
Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria, 9026
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Wien, Austria, 1090
Belgium
CHR de Namur
Namur, Belgium, 5000
France
Polyclinique Louis Pasteur
Essey les Nancy, France, 54270
Hôpital Pontchaillou- CHU
Rennes Cedex, France, 35033
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Universitäres Herz & Gefässzentrum Hamburg
Hamburg, Germany, 22527
Herzzentrum Leipzig
Leipzig, Germany, 04289
Greece
Papageorgiou Hospital
Thessaloniki, Greece, 57001
Italy
Nuovo Ospedale Civile Sant' Agostino
Baggiovara (Modena), Italy, 41100
Casa di Cura Montevergine
Mercogliano, Italy, 83013
Policlinico San Matteo
Pavia, Italy, 27100
Spain
Hospital de Donostia
Donostia-San Sebastian, Spain, 20014
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Thomas Zeller, M.D. Herzzentrum Bad Krozingen, Germany
  More Information

No publications provided

Responsible Party: Ellen Travis, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180505     History of Changes
Other Study ID Numbers: 04-100
Study First Received: September 13, 2005
Last Updated: February 23, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Abbott Vascular:
Peripheral Artery Disease
Restenosis Rate
Patency Rates
Self-Expandable Nitinol Stents
Stent Fractures

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 18, 2014