Rapid Exchange Devices Observational Registry. (RXRegistry)

Terumo

Status: Unknown

Conditions: Peripheral (Lowr Extremity) Arterial Disease.

Study type: Observational

Funder types: Industry

Identifiers

NCT01994798

T122E2

Details and patient eligibility

About

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.

Full description

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
• Rutherford classification 2-5
• Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
• Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
• At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
• Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion criteria

• Female of child-bearing potential.
• Previous bypass surgery
• In stent restenosis as a target lesion
• Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
• Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
• Acute thrombophlebitis or deep venous thrombosis
• Hemodynamic instability
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Known intolerance to study medications, contrast agents or nitinol.