Completed

MAJESTICBoston Scientific's Innova Drug-Eluting Stent for Superficial Femoral and Proximal Popliteal Artery Lesions

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Study Aim

This study aims to treat superficial femoral and proximal popliteal artery lesions using Boston Scientific's Innova Drug-Eluting Stent, with the primary outcome being the assessment of the target lesion's primary patency at 9 months through duplex ultrasound.

What is being tested

Boston Scientific DES SFA Paclitaxel-Eluting Stent

Device
Who is being recruted

Arterial Occlusive Diseases+2

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2013
See protocol details

Summary

Principal SponsorBoston Scientific Corporation
Last updated: March 22, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2013

Actual date on which the first participant was enrolled.

This study focuses on a specific type of stent, the Boston Scientific nitinol drug-eluting stent, and its effectiveness in treating blockages in the Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA). These are blood vessels located in the upper leg and knee area. The goal is to determine if this stent performs well at 9 months post-treatment. The importance of this study lies in potentially providing a reliable treatment option for individuals suffering from blockages in these arteries, which can lead to improved blood flow and reduced risk of complications. Participants in this study will receive the Boston Scientific nitinol drug-eluting stent, which will be placed in the affected artery. The study will then measure the 'primary patency' of the treated area at 9 months. This means checking if the stent has successfully kept the artery open, without any significant narrowing or need for further procedures. This will be assessed using duplex ultrasound, a non-invasive imaging method. The study will also monitor for any potential risks or complications associated with the stent.

NCT01820637
Principal SponsorBoston Scientific Corporation
Last updated: March 22, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

57 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesAtherosclerosis

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: Degree of stenosis ≥70% by visual angiographic assessment Vessel diameter ≥ 4 and ≤ 6mm 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) 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Royal Prince Alfred Hospital

Camperdown, AustraliaOpen Royal Prince Alfred Hospital in Google Maps

Prince of Wales Hospital

Randwick, Australia

Allgemeines Krankenhaus AKH

Vienna, Austria, Austria

AZ Sint-Blasius

Dendermonde, Belgium
Completed13 Study Centers