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Completed

NCT Number: NCT00715416

PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

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.

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Key information

Conditions

Peripheral Vascular Diseases Angioplasty Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nitinol stent

Device

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.

Nitinol Stent Placement

Procedure

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

Other names: 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

Primary outcomes

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

    Time frame: 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

    Time frame: 3, 6, 12 months

Sponsors and collaborators

Lead sponsor

Vienna General Hospital

Other

Registry information

Official study title

Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2008
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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