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

NCT01820637 | Completed Results

• 1 other identifier: S2049
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 11

Brief Summary

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.

Conditions

Atherosclerosis of Native Arteries of the Extremities

Keywords

atherosclerosis; SFA; PPA; lower extremities; stenting; paclitaxel

Outcome Measures

Primary Outcomes (1)

• Primary Patency

  Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.

  9-months

Other Outcomes (1)

• Percentage of Participants With Composite of Major Adverse Events

  9 months

Study Arms (1)

Test device arm (DES SFA)

EXPERIMENTAL

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

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

Interventions

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

Drug-eluting SFA self-expanding stent

Test device arm (DES SFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (13)

Royal Prince Alfred Hospital

Camperdown, Australia

Location

Prince of Wales Hospital

Randwick, Australia

Location

Allgemeines Krankenhaus AKH

Vienna, Austria, Austria

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

Ziekenhuis Oost Limburg

Genk, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH

Bad Krozingen, Germany

Location

Ev. Luth. Diakonissenanstalt Flensburg

Flensburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Universität Leipzig

Leipzig, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

Braemar Hospital

Hamilton, New Zealand

Location

Middlemore Hospital

Otahuhu, New Zealand

Location

Related Publications (2)

• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.

  PMID: 21953370 BACKGROUND

• Muller-Hulsbeck S, Keirse K, Zeller T, Schroe H, Diaz-Cartelle J. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther. 2016 Oct;23(5):701-7. doi: 10.1177/1526602816650206. Epub 2016 May 18.

  PMID: 27193308 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lieve Cornelis, Clinical Trial Manager
• Organization: Boston Scientific

Lieve.Cornelis@bsci.com

+ 32 476-840-183

Study Officials

• Stefan Müller-Hülsbeck, Prof.

  Ev. Luth. Diakonissenanstalt Flensburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 29, 2013
• Study Start: August 23, 2013
• Primary Completion: December 1, 2014
• Study Completion: February 20, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (3); DE (4); NZ (3)