Peripheral Vascular DiseasesXLPAD DES SFANCT03671655
Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents
A study testing Drug-eluting stent and Bare metal stent in people with Peripheral Vascular Diseases and Chronic Total Occlusion of Artery of the Extremities, run by North Texas Veterans Healthcare System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Vascular Diseases, Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- Drug-eluting stent and Bare metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to 31 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Texas Veterans Affairs Health Care System
Dallas, Texas, 75216
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents (XL PAD SFA DES)
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.
Read the detailed description
Current practice of SFA revascularization almost always results in use of a Nitinol (a nickel-titanium alloy) BMS. Balloon angioplasty of complex SFA lesions, such as CTO or ≥60 mm lesions is associated with >50% restenosis at 1-year and Nitinol stents have outperformed stainless-steel stents in the SFA. Debulking strategies are employed selectively and rarely as a stand-alone therapy of SFA CTO. Stent use in long SFA lesions and CTO is fraught with the risk of fracture, mechanical deformation, neo-intimal hyperplasia and thrombosis, each of which is associated with loss of patency. Repeat procedures for in-stent restenosis are technically difficult, carry a higher morbidity compared to the initial procedure and provide less symptom relief. Therefore improving the patency of the initial procedure is in the best interest of the patient and the operator. Though long SFA lesions and CTO constitute ≥50% of all SFA lesions, it is systematically under-represented in the current SFA randomized trials. Stenting has not been shown to be superior to balloon angioplasty for short (30-60 mm) SFA lesions.SFA stenting is associated with lower patency rates and is especially less durable in diabetics, who have a higher prevalence of long lesions and CTO. In one of the largest to date outcome analyses of Nitinol stents in the SFA, 56% of lesions constituted a CTO. Seventy two percent of lesions treated with stents presented with in-stent restenosis compared to 52% of lesions stented for non-CTO lesions (p<0.001). In a multivariate analysis of stent patency, presence of a long lesion or CTO was an independent adverse predictor (hazard rate or HR=5.075, 95% confidence interval or CI 2.715-9.487). It is important to note that the benefit of stents is greater for longer and more complex lesions, including SFA CTO and long (≥60 mm) lesions.
Study subjects will be recruited from the group of patients who are referred for clinically indicated endovascular treatment of SFA for claudication at the Dallas VA Medical Center and at other participating study sites. The study the investigators propose is significant because: (a) it would affect many veterans, (b) the consequences of early SFA stent failure are grave, (c) treatment of SFA lesions is challenging, and (d) outcomes after treatment of SFA lesions are poor and may be improved with DES. In summary, failure of stent patency after initial revascularization with stenting is common and carries significant morbidity. If restenosis rates of SFA stents can be reduced with DES, it could significantly improve procedural success, durability of treatment, quality of life of patients, reduce the need for repeat revascularization procedures, and potentially reduce healthcare costs.
The proposed study is a phase 3, randomized controlled, parallel-group study in patients with long SFA lesions and SFA CTO, undergoing clinically indicated stent-based percutaneous revascularization.
End points :
The primary study end point is binary restenosis, as assessed by duplex ultrasonography performed at 12 months post-procedure or earlier if clinically indicated. Binary restenosis is defined as ≥2.5 fold increase in PSVR within the stented segment and within 10 mm of its proximal and distal edges to that recorded proximal to the stented segment or by the presence of an occluded stent with no flow. Secondary endpoints included change of resting ankle-brachial index (ABI) and symptoms (Rutherford-Becker stages), at 12 months post-procedure. Patients will be asked to complete a walking impairment questionnaire (score range: 0 to 14,080) pre-intervention, and then at 12 months for the first year post-procedure.19 All analyses will be performed in a blinded fashion at the Veterans Affairs North Texas Clinical Angiographic and Ultrasound Core Laboratory and clinical adjudication and adverse events monitoring will be performed by an independent data oversight and safety monitoring board.
Statistical analysis :
The investigators calculated a priori that 55 vascular segments would be needed in each study arm to have 80% power to detect a reduction in binary restenosis from 40% in the BMS arm to 15% in the DES arm, assuming 10% attrition and an alpha of 0.05. Continuous variables will be summarized as mean ± standard deviation and compared using the t-test or the Wilcoxon rank-sum test, as appropriate. Discrete variables will be presented as frequencies and group percentages compared using the chi-square test or Fisher's Exact Test, as appropriate. Freedom from restenosis will be assessed using Kaplan-Meier curves and log-rank test. For all comparisons a two-sided probability of <0.05 will be considered statistically significant. All analyses will be performed using SAS 9.1 (SAS Institute Inc., Cary, North Carolina).
- Being tested
- Drug-eluting stent, Bare metal stent
- Keywords
- Superficial femoral artery, chronic total occlusion
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stentDevice
Also called Zilver PTX stent, Zilver Paclitaxel stent
Drug eluting stent which are nitinol stent coated with Paclitaxel drug
Bare metal stentDevice
Also called Bare metal stent Nitinol stent, SMART, Viabahn
Bare metal stent is Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting stent | Experimental | Drug-eluting stent is nitinol stent coated with Paclitaxel drug Other Names: Zilver PTX stent Zilver Paclitaxel stent Receives: 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 Receives: Device: Bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months - The study was closed due to lower than anticipated eligible participants.
Secondary outcomes (7)
Crossing time
SFA CTO crossing time with wire-catheter technique versus a dedicated CTO crossing device, as per operator discretion
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
Procedural duration
Entire procedural duration from time of getting access to dilating SFA post stenting
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
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
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
Ankle Brachial Index
Change in ABI at 12 months compared to pre-intervention value for the target limb.
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
Rutherford Category
Change in Rutherford category symptoms at 12 months compared to pre-intervention value for the target limb.
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
Walking Impairment Questionnaire (WIQ)
Change in Walking Impairment Questionnaire at 12 months compared to pre-intervention value for the target limb.
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
6 minute Walking Test
Change in 6 minute Walking Test at 12 months compared to pre-intervention value for the target limb.
Measured: 12 months - The study was closed due to lower than anticipated eligible participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startJan 2014
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Why it stopped: The study was terminated as we plan to start a competing study sponsored through VA CSP.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, North Texas Veterans Healthcare System
- Investigators
- Subhash Banerjee, MD, Study chair, North Texas Veterans Health Care System, Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671655
- Sponsor's protocol ID
- Dallas VA IRB #13-098
- Acronym
- XLPAD DES SFA
- Status last verified
- Sep 2018
- First submitted
- 21 Oct 2014
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15653033Rocha-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.
PubMed 17377972Krankenberg 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.
PubMed 17592075Dake 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.
PubMed 21953370Schillinger 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.
PubMed 16672699Banerjee 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.
PubMed 22981558
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excellence in Peripheral Arterial Disease Treatment of Superficial Femoral Artery Disease With Drug-eluting Stents (XL PAD SFA DES)
- ClinicalTrials.gov ID
- NCT03671655
- Acronym / sponsor ID
- XLPAD DES SFA / Dallas VA IRB #13-098
- Keywords
- Superficial femoral artery, chronic total occlusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated as we plan to start a competing study sponsored through VA CSP.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Jan 2014
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current practice of SFA revascularization almost always results in use of a Nitinol (a nickel-titanium alloy) BMS. Balloon angioplasty of complex SFA lesions, such as CTO or ≥60 mm lesions is associated with >50% restenosis at 1-year and Nitinol stents have outperformed stainless-steel stents in the SFA. Debulking strategies are employed selectively and rarely as a stand-alone therapy of SFA CTO. Stent use in long SFA lesions and CTO is fraught with the risk of fracture, mechanical deformation, neo-intimal hyperplasia and thrombosis, each of which is associated with loss of patency. Repeat procedures for in-stent restenosis are technically difficult, carry a higher morbidity compared to the initial procedure and provide less symptom relief. Therefore improving the patency of the initial procedure is in the best interest of the patient and the operator. Though long SFA lesions and CTO constitute ≥50% of all SFA lesions, it is systematically under-represented in the current SFA randomized trials. Stenting has not been shown to be superior to balloon angioplasty for short (30-60 mm) SFA lesions.SFA stenting is associated with lower patency rates and is especially less durable in diabetics, who have a higher prevalence of long lesions and CTO. In one of the largest to date outcome analyses of Nitinol stents in the SFA, 56% of lesions constituted a CTO. Seventy two percent of lesions treated with stents presented with in-stent restenosis compared to 52% of lesions stented for non-CTO lesions (p<0.001). In a multivariate analysis of stent patency, presence of a long lesion or CTO was an independent adverse predictor (hazard rate or HR=5.075, 95% confidence interval or CI 2.715-9.487). It is important to note that the benefit of stents is greater for longer and more complex lesions, including SFA CTO and long (≥60 mm) lesions.
Study subjects will be recruited from the group of patients who are referred for clinically indicated endovascular treatment of SFA for claudication at the Dallas VA Medical Center and at other participating study sites. The study the investigators propose is significant because: (a) it would affect many veterans, (b) the consequences of early SFA stent failure are grave, (c) treatment of SFA lesions is challenging, and (d) outcomes after treatment of SFA lesions are poor and may be improved with DES. In summary, failure of stent patency after initial revascularization with stenting is common and carries significant morbidity. If restenosis rates of SFA stents can be reduced with DES, it could significantly improve procedural success, durability of treatment, quality of life of patients, reduce the need for repeat revascularization procedures, and potentially reduce healthcare costs.
The proposed study is a phase 3, randomized controlled, parallel-group study in patients with long SFA lesions and SFA CTO, undergoing clinically indicated stent-based percutaneous revascularization.
End points :
The primary study end point is binary restenosis, as assessed by duplex ultrasonography performed at 12 months post-procedure or earlier if clinically indicated. Binary restenosis is defined as ≥2.5 fold increase in PSVR within the stented segment and within 10 mm of its proximal and distal edges to that recorded proximal to the stented segment or by the presence of an occluded stent with no flow. Secondary endpoints included change of resting ankle-brachial index (ABI) and symptoms (Rutherford-Becker stages), at 12 months post-procedure. Patients will be asked to complete a walking impairment questionnaire (score range: 0 to 14,080) pre-intervention, and then at 12 months for the first year post-procedure.19 All analyses will be performed in a blinded fashion at the Veterans Affairs North Texas Clinical Angiographic and Ultrasound Core Laboratory and clinical adjudication and adverse events monitoring will be performed by an independent data oversight and safety monitoring board.
Statistical analysis :
The investigators calculated a priori that 55 vascular segments would be needed in each study arm to have 80% power to detect a reduction in binary restenosis from 40% in the BMS arm to 15% in the DES arm, assuming 10% attrition and an alpha of 0.05. Continuous variables will be summarized as mean ± standard deviation and compared using the t-test or the Wilcoxon rank-sum test, as appropriate. Discrete variables will be presented as frequencies and group percentages compared using the chi-square test or Fisher's Exact Test, as appropriate. Freedom from restenosis will be assessed using Kaplan-Meier curves and log-rank test. For all comparisons a two-sided probability of <0.05 will be considered statistically significant. All analyses will be performed using SAS 9.1 (SAS Institute Inc., Cary, North Carolina).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting stent | Experimental | Device: Drug-eluting stentDrug-eluting stent is nitinol stent coated with Paclitaxel drug Other Names: Zilver PTX stent Zilver Paclitaxel stent |
| Bare metal stent | Active comparator | Device: Bare metal stentBare metal stentis Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-eluting stentAlso: Zilver PTX stent, Zilver Paclitaxel stentDrug eluting stent which are nitinol stent coated with Paclitaxel drug | Device | Drug-eluting stent |
| Bare metal stentAlso: Bare metal stent Nitinol stent, SMART, ViabahnBare metal stent is Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent | Device | Bare metal stent |
Primary outcome
SFA stent patency
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants.
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.
7 secondary outcomes
Crossing time
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Procedural duration
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Composite of Major Adverse Events
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Ankle Brachial Index
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Rutherford Category
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Walking Impairment Questionnaire (WIQ)
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
6 minute Walking Test
Time frame: 12 months - The study was closed due to lower than anticipated eligible participants
Results and safety
The study was stopped early (reason given: The study was terminated as we plan to start a competing study sponsored through VA CSP.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Background: PubMed 15653033Scheinert 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.
- Background: PubMed 17377972Rocha-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.
- Background: PubMed 17592075Krankenberg 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.
- Background: PubMed 21953370Dake 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.
- Background: PubMed 16672699Schillinger 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.
- Background: PubMed 22981558Banerjee 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.
- Individual participant dataSharing planned: No
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Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhash Banerjee, MD study chair
North Texas Veterans Health Care System, Dallas, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stent and Bare metal stent in people with Peripheral Vascular Diseases and Chronic Total Occlusion of Artery of the Extremities, run by North Texas Veterans Healthcare System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated as we plan to start a competing study sponsored through VA CSP.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SFA stent patency (time frame: 12 months - The study was closed due to lower than anticipated eligible participants.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671655, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.