The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people with peripheral arterial disease who have symptoms from blocked or narrowed arteries in the thigh and knee area. Their doctor must judge that they can be treated with the DETOUR System.

Nem

All sexes can join.

A betegség stádiuma

Symptomatic femoropopliteal lesions (thigh and knee arteries) from 200 mm to 460 mm long. These are either full long-term blockages (100 mm to 425 mm) or widespread narrowing of more than 70%. People may be poor candidates for surgery or other treatments done inside the blood vessels.

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis > 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.

A vizsgálat 2 csoportja

• As Treated

  All patients that have received the therapy; patients treated within and outside the IFU criteria subgroups; male and female subgroups; and duplex imaging subgroups for arterial and venous observations.

  Kezelés: DETOUR System

• Imaging Cohort

  Sites that are performing (arterial and venous) duplex ultrasound assessments according to the institution's standard practice will be asked to participate in the DUS imaging cohort. The Imaging sub-study will consist of 55 female and 55 male subjects from these sites. Duplex imaging at 1-, 12-, 24-, and 36-months post-procedure will be collected to assess the endpoints of graft patency and venous thrombus within the vein containing the graft (n=110).

  Kezelés: DETOUR System