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
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, see Learn About Clinical Studies.

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 August 20, 2014