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

V

Vienna General Hospital

Status and phase

Completed
Phase 4

Conditions

Peripheral Vascular Diseases
Angioplasty
Intermittent Claudication

Treatments

Device: Nitinol stent
Procedure: Nitinol Stent Placement

Study type

Interventional

Funder types

Other

Identifiers

NCT00715416
1.1/2006

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

1
Experimental group
Description:
primary nitinol stent placement of superficial femoral artery lesions
Treatment:
Procedure: Nitinol Stent Placement
Device: Nitinol stent
2
Active Comparator group
Description:
balloon angioplasty of superficial artery lesions with secondary stent placement in case of >30% residual stenosis after the procedure
Treatment:
Device: Nitinol stent

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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