NCT00281060

Brief Summary

Minimal invasive treatment (called "endovascular") of the arteries of the lower limb remains problematic, because recurrent disease ("restenosis") frequently leads to recurrent symptoms. As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial femoral artery (artery of the thigh). We investigated whether the use of a vascular endoprosthesis ("stent") improves patients´ outcome. Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
Last Updated

July 27, 2006

Status Verified

August 1, 2005

First QC Date

January 20, 2006

Last Update Submit

July 26, 2006

Conditions

Atherosclerosis

Keywords

endovascularballoon angioplastystents

Outcome Measures

Primary Outcomes (1)

  • Angiographic restenosis at 6 months

Secondary Outcomes (4)

  • restenosis by duplex ultrasound at 3,6 and 12 months

  • walking distance on the treadmill at 3, 6 and 12 months

  • ankle brachial index at 3, 6 and 12 months

  • stent fractures at 6 and 12 months

Interventions

primary stentingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic peripheral artery disease Rutherford stages 3 to 5
  • \>50% stenosis of the ipsilateral superficial femoral artery
  • Lesion length \>30mm
  • At least one patent crural run-off vessel,

You may not qualify if:

  • Acute criticla limb ischemia
  • Previous ipsilateral bypass surgery or ipsilateral SFA stenting
  • Untreated inflow disease
  • Known intolerance to clopidogrel, aspirin or radiocontrast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, A 1090, Austria

Location

Related Publications (1)

  • Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.

    PMID: 16672699RESULT

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Schillinger, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 24, 2006

Study Start

June 1, 2003

Study Completion

August 1, 2005

Last Updated

July 27, 2006

Record last verified: 2005-08

Locations

AU(1)