ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00715416
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : July 15, 2008
Sponsor:
Information provided by:
Vienna General Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
Study Start Date : June 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Prof. Martin Schillinger, General Hospital of Vienna
ClinicalTrials.gov Identifier: NCT00715416     History of Changes
Other Study ID Numbers: 1.1/2006
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: July 15, 2008
Last Verified: January 2006

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

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