Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery

Summary

Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10% of the patients the ischemia worsens to threat the vitality of the limb. Although intermittent claudication has a benign prognosis and can often treated conservatively, more severe forms with extensive arterial obstructions require revascularization, either open surgical or endovascular. Surgical bypass operations are currently the standard reference for treating long femoral artery obstructions. Surgical bypass operations are accompanied by significant acute complications and late adverse effects, especially in patients with associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and effective endovascular therapies are seeked for. The long term patency rates of infrainguinal balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when long femoral arterial obstructions have been treated. Drug eluting stents have shown great promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25 cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and chronic critical ischemia patients. The aim is to randomize altogether 400 patients during about two years in five universities and in 2-3 central hospitals. The primary end point is patency at 24 month follow up. Secondary end points are primary success at patient discharge, complications, 30-day mortality, target lesion revascularization, quality of life, and economical analysis.

Conditions

• Chronic Lower Limb Ischemia
• Peripheral Athero Obstructive Disease
• Critical Ischemia
• Claudication

Interventions

PROCEDURE

bypass surgery, stent placement

bypass surgery, stent placement

PROCEDURE

stent placement

placement of paclitaxel eluting stent in long superficial femoral artery obstruction

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Tampere University Hospital

  collaborator OTHER

• Oulu University Hospital

  collaborator OTHER

• Finnish Society of Interventional radiology

  collaborator UNKNOWN

• North Karelia Central Hospital

  collaborator OTHER

• Paijat-Hame Hospital District

  collaborator OTHER

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Hannu I Manninen, Professor · Kuopio University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Finland

Study Locations