Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project (MAJESTIC)

Boston Scientific

Status: Completed

Conditions: Atherosclerosis of Native Arteries of the Extremities

Treatments: Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820637

S2049

Details and patient eligibility

About

To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects age 18 and older

• Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

• Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:

  1. Degree of stenosis ≥70% by visual angiographic assessment

  2. Vessel diameter ≥ 4 and ≤ 6mm

  3. Total lesion length (or series of lesions) ≥30 mm and ≤110 mm

     • (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)

  4. Target lesion located at least three centimeters above the inferior edge of the femur

• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Test device arm (DES SFA)

Experimental group

Description:

Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)

Treatment:

Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)