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

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