Peripheral Vascular Diseases Clinical Trial
— XLPAD DES SFAOfficial title:
Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents (XL PAD SFA DES)
Verified date | September 2018 |
Source | North Texas Veterans Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 31, 2015 |
Est. primary completion date | August 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 years or older 2. Referred for clinically indicated lower extremity angiography and peripheral arterial intervention 3. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up. 4. Absence of allergy to both clopidogrel and aspirin 5. Negative pregnancy test or breast-feeding 6. 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 7. Serum creatinine <2.5 mg/dL 8. Baseline hemoglobin >9 g/dl 9. Baseline platelet count >80,000/L 10. Absence of prior stroke or transient ischemic attack within 3 months 11. =30 days from any prior surgical or endovascular procedure Angiographic enrollment criteria: 1. Undergoing SFA revascularization with the intention for stent implantation 2. De novo SFA lesion =60 mm in length by visual estimation 3. Successfully crossed de novo SFA CTO of any length by visual estimation Exclusion Criteria: 1. SFA lesion involving <5mm of ostial SFA and/or profunda femoris artery take-off 2. SFA lesion extending below the medial femoral epicondyle 3. <1 vessel below-the knee (BTK) run-off |
Country | Name | City | State |
---|---|---|---|
United States | North Texas Veterans Affairs Health Care System | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
North Texas Veterans Healthcare System |
United States,
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. — View Citation
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. — View Citation
Krankenberg H, Schlüter M, Steinkamp HJ, Bürgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tübler 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. Epub 2007 Jun 25. — View Citation
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. — View Citation
Scheinert D, Scheinert S, Sax J, Piorkowski C, Bräunlich 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Crossing time | SFA CTO crossing time with wire-catheter technique versus a dedicated CTO crossing device, as per operator discretion | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | Procedural duration | Entire procedural duration from time of getting access to dilating SFA post stenting | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | Composite of Major Adverse Events | the incidence of major adverse events (composite of all cause death, non-fatal myocardial infarction, unplanned surgical revascularization of the treated limb or amputation of the treated limb) and major bleeding (defined by GUSTO trial criteria) during the 12-month study period | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | Ankle Brachial Index | Change in ABI at 12 months compared to pre-intervention value for the target limb. | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | Rutherford Category | Change in Rutherford category symptoms at 12 months compared to pre-intervention value for the target limb. | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | Walking Impairment Questionnaire (WIQ) | Change in Walking Impairment Questionnaire at 12 months compared to pre-intervention value for the target limb. | 12 months - The study was closed due to lower than anticipated eligible participants | |
Secondary | 6 minute Walking Test | Change in 6 minute Walking Test at 12 months compared to pre-intervention value for the target limb. | 12 months - The study was closed due to lower than anticipated eligible participants |
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