Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents

NCT03671655 | Terminated DMC

• 1 other identifier: Dallas VA IRB #13-098
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

The superficial femoral artery (SFA) is frequently involved in atherosclerosis and is the most common target of lower extremity endovascular procedures performed in patients with claudication. Endovascular treatment of SFA is challenging, given its exceptional predisposition to atherosclerosis and its exposure to extreme mechanical forces of extension, compression, torsion and flexion. The SFA is located in a fibro-muscular canal, follows a tortuous course and is considered a 'hostile' location for endovascular procedures, especially stents due to the risk of stent fracture. On the other hand, durability of balloon angioplasty in the SFA is dismal (25% patency at 1 year). Therefore, Nitinol (a metal alloy of nickel and titanium) stent implantation is the mainstay of endovascular SFA interventions when balloon angioplasty (PTA) leads to sub-optimal results during a procedure. It is used in over 70% of all cases and in nearly 100% of all femoro-popliteal (FP) CTO (chronic total occlusions) and long (≥60 mm) interventions. Endovascular treatment of SFA is challenging and restenosis is the most common cause for the lack of durability of a SFA peripheral vascular interventional procedure.5 Restenosis rates of SFA bare metal (nitinol) stents or BMS at 1 year exceeds 50% for lesions ≥60 mm in length or CTO. Stent based treatment of the SFA may not offer any additional advantage for short non-CTO (\<60 mm) lesions compared to PTA. In a recent study, primarily comparing drug-eluting stents (DES) to balloon angioplasty in the SFA, 12 month patency rates were 83.1% and 32.8%, respectively for DES and balloon angioplasty arms. However, there are no head-to head studies randomized studies comparing DES and BMS in the SFA. Thus, endovascular SFA intervention in patients with symptomatic PAD is an area of urgent need for high-quality evidence as volume of these procedures continues to rise exponentially in the U.S. and around the world, largely on the basis of insufficient evidence.Thus, the purpose of this study is to conduct a randomized pilot trial comparing DES and BMS for percutaneous revascularization of SFA.

Conditions

Peripheral Vascular Diseases; Chronic Total Occlusion of Artery of the Extremities

Keywords

Superficial femoral artery; chronic total occlusion

Outcome Measures

Primary Outcomes (1)

• SFA stent patency

  The primary endpoint is to compare the SFA stent patency (defined as peak systolic velocity ration or PSVR≥2.5) at 12 months following percutaneous revascularization of SFA with implantation of either DES or BMS, assigned randomly to each lesion.

  12 months - The study was closed due to lower than anticipated eligible participants.

Secondary Outcomes (7)

• Crossing time

  12 months - The study was closed due to lower than anticipated eligible participants

• Procedural duration

  12 months - The study was closed due to lower than anticipated eligible participants

• Composite of Major Adverse Events

  12 months - The study was closed due to lower than anticipated eligible participants

• Ankle Brachial Index

  12 months - The study was closed due to lower than anticipated eligible participants

• Rutherford Category

  12 months - The study was closed due to lower than anticipated eligible participants

Study Arms (2)

Drug-eluting stent

EXPERIMENTAL

Drug-eluting stent is nitinol stent coated with Paclitaxel drug Other Names: Zilver PTX stent Zilver Paclitaxel stent

Device: Drug-eluting stent

Bare metal stent

ACTIVE COMPARATOR

Bare metal stentis Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent

Device: Bare metal stent

Interventions

Drug-eluting stent DEVICE

Drug eluting stent which are nitinol stent coated with Paclitaxel drug

Also known as: Zilver PTX stent, Zilver Paclitaxel stent

Drug-eluting stent

Bare metal stent DEVICE

Bare metal stent is Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent

Also known as: Bare metal stent Nitinol stent, SMART, Viabahn

Bare metal stent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Referred for clinically indicated lower extremity angiography and peripheral arterial intervention
• Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
• Absence of allergy to both clopidogrel and aspirin
• Negative pregnancy test or breast-feeding
• No coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol as per the site investigator
• Serum creatinine \<2.5 mg/dL
• Baseline hemoglobin \>9 g/dl
• Baseline platelet count \>80,000/L
• Absence of prior stroke or transient ischemic attack within 3 months
• ≥30 days from any prior surgical or endovascular procedure
• Angiographic enrollment criteria:
• Undergoing SFA revascularization with the intention for stent implantation
• De novo SFA lesion ≥60 mm in length by visual estimation
• Successfully crossed de novo SFA CTO of any length by visual estimation

You may not qualify if:

• SFA lesion involving \<5mm of ostial SFA and/or profunda femoris artery take-off
• SFA lesion extending below the medial femoral epicondyle
• \<1 vessel below-the knee (BTK) run-off

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (2)

North Texas Veterans Affairs Health Care System

Dallas, Texas, 75216, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (6)

• Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005 Jan 18;45(2):312-5. doi: 10.1016/j.jacc.2004.11.026.

  PMID: 15653033 BACKGROUND

• Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.

  PMID: 17377972 BACKGROUND

• Krankenberg H, Schluter M, Steinkamp HJ, Burgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tubler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. doi: 10.1161/CIRCULATIONAHA.107.689141. Epub 2007 Jun 25.

  PMID: 17592075 BACKGROUND

• 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

• Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.

  PMID: 16672699 BACKGROUND

• Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, Shammas NW, Tran DL, Zankar A, Varghese C, Kelly KC, Weideman RA, Little BB, Reilly RF, Addo T, Brilakis ES. Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial. J Am Coll Cardiol. 2012 Oct 9;60(15):1352-9. doi: 10.1016/j.jacc.2012.05.042. Epub 2012 Sep 12.

  PMID: 22981558 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Subhash Banerjee, MD

  North Texas Veterans Health Care System, Dallas, TX

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient and study coordinator performing patient follow-up will be blinded to the allocated treatment strategy. Angiographic and US analyses will also be done blinded to study-arm allocation. Breaking the blind will be possible for any patient who develops a complication or whose clinical care requires knowledge of the study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology

Model Details: This is a phase 3, multi-center, randomized controlled, parallel-group study in patients with long Superficial Femoral Artery (SFA) lesions and SFA Chronic Total Occlusion (CTO), undergoing clinically indicated stent-based percutaneous revascularization .Patients will be randomized into Drug eluting stent (DES) arm (intervention) vs. Bare Metal Stent (BMS) arm (control).

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: September 14, 2018
• Study Start: January 1, 2014
• Primary Completion: August 31, 2015
• Study Completion: August 31, 2015
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)