NCT00715416

Brief Summary

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2004

Longer than P75 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, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

July 15, 2008

Status Verified

January 1, 2006

Enrollment Period

3.7 years

First QC Date

July 11, 2008

Last Update Submit

July 11, 2008

Conditions

Peripheral Vascular DiseasesIntermittent ClaudicationAngioplasty

Keywords

peripheral vascular diseasesIntermittent ClaudicationAngioplasty

Outcome Measures

Primary Outcomes (1)

  • occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).

    3, 6, 12 months

Secondary Outcomes (1)

  • ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure

    3, 6, 12 months

Study Arms (2)

1

EXPERIMENTAL

primary nitinol stent placement of superficial femoral artery lesions

Device: Nitinol stentProcedure: Nitinol Stent Placement

2

ACTIVE COMPARATOR

balloon angioplasty of superficial artery lesions with secondary stent placement in case of \>30% residual stenosis after the procedure

Device: Nitinol stent

Interventions

Nitinol stentDEVICE

Interventions are performed percutaneously from either an antegrade or an over-the-bifurcation approach. After insertion of an 6 French sheath, 5000 IU of heparin are administered intra-arterially. After passage of the stenosis/occlusion with the guide wire, patients are randomized to either PTA or primary stent implantation. For standardized documentation of the lesion morphology and comparability during follow-up, a ruler is fixed at the patients thigh with the distal end exactly overlapping at the upper edge of the patella. As a bail-out procedure in the PTA group, stent placement is performed in cases with a residual stenosis of more than 30% in the worst view angiogram.

12
Nitinol Stent PlacementPROCEDURE

Balloon angioplasty compared to primary stent implantation for long segment superficial femoral artery lesions

Also known as: Product: peripheral stent system, Type: ASTRON, EC class: IIb, Certificate number: G1 01 10 10275 193, EC number: 0123, Date of issue: 26.10.2001
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
  • critical limb ischemia in patients with stenosis or occlusions originating in the SFA
  • up to 25 cm length of stenosis/occlusion

You may not qualify if:

  • previous bypass surgery at the site of treatment
  • history of intolerance of anti-platelet therapy
  • adverse reaction to heparin
  • bleeding diathesis
  • creatinine \>2.5 mg/dL
  • active bacterial infection
  • allergy to contrast media
  • previous stent placement at or immediately adjacent to the target lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Vienna

Vienna, Vienna, 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: 16672699BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular DiseasesIntermittent Claudication

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Schilliger, Prof

    General Hospital of Vienna, Department of Angiology

    PRINCIPAL INVESTIGATOR

  • Martin Schillinger, Prof

    General Hospital of 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

July 11, 2008

First Posted

July 15, 2008

Study Start

June 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 15, 2008

Record last verified: 2006-01

Locations

AU(1)