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

This study has been completed.
Sponsor:
Information provided by:
Vienna General Hospital
ClinicalTrials.gov Identifier:
NCT00715416
First received: July 11, 2008
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Intermittent Claudication
Angioplasty
Device: Nitinol stent
Procedure: Nitinol Stent Placement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Vienna General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: June 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
primary nitinol stent placement of superficial femoral artery lesions
Device: Nitinol stent
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.
Procedure: Nitinol Stent Placement
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
Active Comparator: 2
balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure
Device: Nitinol stent
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715416

Locations
Austria
University Hospital of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Vienna General Hospital
Investigators
Principal Investigator: Martin Schilliger, Prof General Hospital of Vienna, Department of Angiology
Principal Investigator: Martin Schillinger, Prof General Hospital of Vienna
  More Information

Publications:
Responsible Party: Prof. Martin Schillinger, General Hospital of Vienna
ClinicalTrials.gov Identifier: NCT00715416     History of Changes
Other Study ID Numbers: 1.1/2006
Study First Received: July 11, 2008
Last Updated: July 11, 2008
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Vienna General Hospital:
peripheral vascular diseases
Intermittent Claudication
Angioplasty

Additional relevant MeSH terms:
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on April 17, 2014