膝上大腿膝窩動脈におけるZilver PTX薬剤溶出ステントの評価

基本情報

NCT ID: NCT00120406
ステータス: 完了
試験のフェーズ: 該当なし
試験タイプ: 介入
目標被験者数: 474
治験依頼者名: Cook Group Incorporated

概要

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).

対象疾患

Peripheral Vascular Diseases

介入

Zilver® PTX™ Drug Eluting Vascular Stent(DEVICE)

Angioplasty(PROCEDURE)

依頼者（Sponsor）

William Cook Europe(INDUSTRY)

Med Institute, Incorporated(INDUSTRY)

Cook Group Incorporated(INDUSTRY)

Cook Japan Incorporated(INDUSTRY)

実施施設 (4)

小倉記念病院

Kitakyushu, Fukuoka, Japan

京都大学医学部附属病院

Kyoto, Japan

東京慈恵会医科大学附属病院

Nishi-Shinbashi, Minato-ku, Japan

公立大学法人　奈良県立医科大学附属病院

Nara, Japan