Stent RestenosisBIOFLEX-COFNCT03097679
Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions
A study testing Pulsar Stent and LifeStent Flexstar Vascular Stent in people with Stent Restenosis and Intimal Hyperplasia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Restenosis, Intimal Hyperplasia
- What is being tested?
- Pulsar Stent and LifeStent Flexstar Vascular Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2015to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient related:
- Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
- At least 18 years of age.
- Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
- Projected life expectancy of greater than two years.
- The ability to comply with protocol follow-up requirements and required testing.
Show all 17Show fewer
- Clinical:
- Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.
- Resting ankle-brachial index (ABI) ≤ 0.8 in the study limb.
- Inflow lesion - if present - has been treated successfully (inflow treatment in same procedure permissible)
- Angiographic and Lesion Requirements (assessed intraoperatively):
- TASC A-D lesions from stenoses /occlusions ≤ 35cm.
- Popliteal artery is patent 5 cm proximal to the radiographic knee joint line.
- Reference diameter of 4.0 - 7.0 mm in proximal and distal treatment segments within the SFA.
- Patent SFA orifice (the proximal 5 mm after femoral bifurcation).
- At least one patent (<50% stenotic) inflow vessel present, proven angiographically. Study eligibility is given when inflow lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.
- At least one patent (<50% stenotic)tibial artery runoff to the ankle present, proven angiographically. Study eligibility is given when runoff vessel lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel.
Who cannot join
- Pregnant and/or breast-feeding women.
- Lesion length > 35 cm.
- Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.
- Previous stenting or femoral bypass surgery in the target vessel.
- Clinical relevant aneurysmatic disease of the abdominal aorta, ipsilateral femoral arteries or arteries of the knee.
- Rutherford stage 0, 1 or 6
Show all 17Show fewer
- Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
- Septicaemia.
- Ischemic stroke within the last three months.
- Any previously known coagulation disorder, including hypercoagulability
- Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
- Contraindication to anticoagulation or antiplatelet therapy.
- Known allergy to medication or contrast media used in this trial, if pre-treatment is not possible (physician's discretion).
- Known allergies to stent components (especially Nickel).
- Severe calcification of the target lesion.
- Current participation in another clinical research trial, that has not reached its primary endpoint.
- The patient is institutionalized based on a legal verdict.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).
Read the detailed description
Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Data about COF and neointimal hyperplasia in humans are currently lacking. Some animal studies, though, found a markedly increased neointimal hyperplasia in stents with high oversizing and thus high COF. The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar). Diameter of implanted stents will be measured at every two millimetres along the stent axis on DICOM images of the respective completion angiography using image processing software.
The scheduled time for recruitment is 2 years. There will be two follow-up evaluations at 12 and 24 months.
Primary endpoint is the amount of in-stent neointima at one year, assessed by contrast-enhanced CT angiography (CTA). Secondary objectives are the amount of in-stent neointima at two years, device- and procedure-related adverse events and target lesion revascularisation (TLR) rate.
In the control examinations stent diameter and true lumen diameter will be measured on DICOM images every two millimetres along the stent axis to quantify the relative amount of in-stent restenosis.
The present study is challenging in that it compares two different self-expanding nitinol-stents head-to-head against each other. To optimize the power of this study, both clinical TLR and binary re-stenosis at Colour flow Doppler Ultrasound were dropped as primary endpoints. Instead the amount of neointima inside the stent accessed by CTA was selected as outcome parameter.
The study differs further from similar previous trials in its generous inclusions criteria. This was done in effort to perform the trial on a patient sample that closely represents real-world patients of a specialised endovascular centre.
- Conditions
- Stent Restenosis, Intimal Hyperplasia
- Being tested
- Pulsar Stent, LifeStent Flexstar Vascular Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsar StentDevice
Percutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
LifeStent Flexstar Vascular StentDevice
Percutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
| Study group | Role | What they receive |
|---|---|---|
| low COF-group | Active comparator | The low COF-group receives a thin-strut stent (Pulsar, Biotronik AG, Bülach, Switzerland) with minimal oversizing (according to manufacturer's Instructions For Use) Receives: Device: Pulsar Stent |
| high COF-group | Active comparator | The high COF-group receives a stiffer-stent (Lifestent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) with maximal oversizing (according to manufacturer's Instructions For Use). Receives: Device: LifeStent Flexstar Vascular Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of in-stent restenosis
Mean amount of in-stent restenosis in percent along the stent axis at one and two years post-procedure.
Measured: one and two years post-procedure
Secondary outcomes (2)
Adverse Events ISO 14155:2011
Adverse Events ISO 14155:2011
Measured: within two years post-procedure
Target lesion revascularisation (TLR)
In patients with TLR the amount of in-stent restenosis will be assessed at the time of TLR.
Measured: within two years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Oct 2015
- Primary completion31 Jul 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Stent RestenosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Wressnegger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097679
- Sponsor's protocol ID
- 1026/2015
- Acronym
- BIOFLEX-COF
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Beschorner U, Ristl R, Schoder M. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol. 2015 Feb;38(1):25-32. doi: 10.1007/s00270-014-1024-9. Epub 2014 Dec 5.
PubMed 25472936Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, Reekers J, Norgren L. An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II): The TASC Steering Comittee(.). Ann Vasc Dis. 2015;8(4):343-57. doi: 10.3400/avd.tasc.15-01000. Epub 2015 Oct 23.
PubMed 26730266Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. J Vasc Interv Radiol. 2008 Jun;19(6):823-32. doi: 10.1016/j.jvir.2008.02.008. Epub 2008 Apr 10.
PubMed 18503895Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
PubMed 25775675Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
PubMed 19859954Krankenberg 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 21953370Deloose K, Lauwers K, Callaert J, Maene L, Keirse K, Verbist J, Peeters P, Bosiers M. Drug-eluting technologies in femoral artery lesions. J Cardiovasc Surg (Torino). 2013 Apr;54(2):217-24.
PubMed 23558657Brodmann M. Prime time for drug eluting balloons in SFA interventions? J Cardiovasc Surg (Torino). 2014 Aug;55(4):461-4. Epub 2014 Jun 18.
PubMed 24941235Minar E, Schillinger M. Innovative technologies for SFA occlusions: drug coated balloons in SFA lesions. J Cardiovasc Surg (Torino). 2012 Aug;53(4):481-6.
PubMed 22854528Schmidt W, Wissgott C, Andresen R, Behrens P, Schmitz KP. Performance characteristics of modern self-expanding nitinol stents indicated for SFA. Rofo. 2011 Sep;183(9):818-25. doi: 10.1055/s-0031-1273445. Epub 2011 Jul 12.
PubMed 21751121Johnston CR, Lee K, Flewitt J, Moore R, Dobson GM, Thornton GM. The mechanical properties of endovascular stents: an in vitro assessment. Cardiovasc Eng. 2010 Sep;10(3):128-35. doi: 10.1007/s10558-010-9097-9.
PubMed 20717726Cho H, Nango M, Sakai Y, Sohgawa E, Kageyama K, Hamamoto S, Kitayama T, Yamamoto A, Miki Y. Neointimal hyperplasia after stent placement across size-discrepant vessels in an animal study. Jpn J Radiol. 2014 Jun;32(6):340-6. doi: 10.1007/s11604-014-0311-3. Epub 2014 Apr 9.
PubMed 24715330Zhao HQ, Nikanorov A, Virmani R, Jones R, Pacheco E, Schwartz LB. Late stent expansion and neointimal proliferation of oversized Nitinol stents in peripheral arteries. Cardiovasc Intervent Radiol. 2009 Jul;32(4):720-6. doi: 10.1007/s00270-009-9601-z. Epub 2009 May 30.
PubMed 19484292Freeman JW, Snowhill PB, Nosher JL. A link between stent radial forces and vascular wall remodeling: the discovery of an optimal stent radial force for minimal vessel restenosis. Connect Tissue Res. 2010 Aug;51(4):314-26. doi: 10.3109/03008200903329771.
PubMed 20388019
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions
- ClinicalTrials.gov ID
- NCT03097679
- Acronym / sponsor ID
- BIOFLEX-COF / 1026/2015
- Conditions
- Stent Restenosis, Intimal Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Mar 2017 (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 objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).
Detailed description
Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Data about COF and neointimal hyperplasia in humans are currently lacking. Some animal studies, though, found a markedly increased neointimal hyperplasia in stents with high oversizing and thus high COF. The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar). Diameter of implanted stents will be measured at every two millimetres along the stent axis on DICOM images of the respective completion angiography using image processing software.
The scheduled time for recruitment is 2 years. There will be two follow-up evaluations at 12 and 24 months.
Primary endpoint is the amount of in-stent neointima at one year, assessed by contrast-enhanced CT angiography (CTA). Secondary objectives are the amount of in-stent neointima at two years, device- and procedure-related adverse events and target lesion revascularisation (TLR) rate.
In the control examinations stent diameter and true lumen diameter will be measured on DICOM images every two millimetres along the stent axis to quantify the relative amount of in-stent restenosis.
The present study is challenging in that it compares two different self-expanding nitinol-stents head-to-head against each other. To optimize the power of this study, both clinical TLR and binary re-stenosis at Colour flow Doppler Ultrasound were dropped as primary endpoints. Instead the amount of neointima inside the stent accessed by CTA was selected as outcome parameter.
The study differs further from similar previous trials in its generous inclusions criteria. This was done in effort to perform the trial on a patient sample that closely represents real-world patients of a specialised endovascular centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low COF-group | Active comparator | Device: Pulsar StentThe low COF-group receives a thin-strut stent (Pulsar, Biotronik AG, Bülach, Switzerland) with minimal oversizing (according to manufacturer's Instructions For Use) |
| high COF-group | Active comparator | Device: LifeStent Flexstar Vascular StentThe high COF-group receives a stiffer-stent (Lifestent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) with maximal oversizing (according to manufacturer's Instructions For Use). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
- At least 18 years of age.
- Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
- Projected life expectancy of greater than two years.
- The ability to comply with protocol follow-up requirements and required testing.
Key exclusion criteria (17 listed)
- Pregnant and/or breast-feeding women.
- Lesion length > 35 cm.
- Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.
- Previous stenting or femoral bypass surgery in the target vessel.
- Clinical relevant aneurysmatic disease of the abdominal aorta, ipsilateral femoral arteries or arteries of the knee.
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 |
|---|---|---|
| Pulsar StentPercutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease. | Device | low COF-group |
| LifeStent Flexstar Vascular StentPercutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease. | Device | high COF-group |
Primary outcome
Amount of in-stent restenosis
Time frame: one and two years post-procedure
Mean amount of in-stent restenosis in percent along the stent axis at one and two years post-procedure.
2 secondary outcomes
Adverse Events ISO 14155:2011
Time frame: within two years post-procedure
Target lesion revascularisation (TLR)
Time frame: within two years post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 25472936Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Beschorner U, Ristl R, Schoder M. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol. 2015 Feb;38(1):25-32. doi: 10.1007/s00270-014-1024-9. Epub 2014 Dec 5.
- Background: PubMed 26730266Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, Reekers J, Norgren L. An Update on Methods for Revascularization and Expansion of the TASC Lesion Classification to Include Below-the-Knee Arteries: A Supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II): The TASC Steering Comittee(.). Ann Vasc Dis. 2015;8(4):343-57. doi: 10.3400/avd.tasc.15-01000. Epub 2015 Oct 23.
- Background: PubMed 18503895Saxon RR, Dake MD, Volgelzang RL, Katzen BT, Becker GJ. Randomized, multicenter study comparing expanded polytetrafluoroethylene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. J Vasc Interv Radiol. 2008 Jun;19(6):823-32. doi: 10.1016/j.jvir.2008.02.008. Epub 2008 Apr 10.
- Background: PubMed 25775675Rastan A, Krankenberg H, Baumgartner I, Blessing E, Muller-Hulsbeck S, Pilger E, Scheinert D, Lammer J, Beschorner U, Noory E, Neumann FJ, Zeller T. Stent placement vs. balloon angioplasty for popliteal artery treatment: two-year results of a prospective, multicenter, randomized trial. J Endovasc Ther. 2015 Feb;22(1):22-7. doi: 10.1177/1526602814564386.
- Background: PubMed 19859954Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
- 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 23558657Deloose K, Lauwers K, Callaert J, Maene L, Keirse K, Verbist J, Peeters P, Bosiers M. Drug-eluting technologies in femoral artery lesions. J Cardiovasc Surg (Torino). 2013 Apr;54(2):217-24.
- Background: PubMed 24941235Brodmann M. Prime time for drug eluting balloons in SFA interventions? J Cardiovasc Surg (Torino). 2014 Aug;55(4):461-4. Epub 2014 Jun 18.
- Background: PubMed 22854528Minar E, Schillinger M. Innovative technologies for SFA occlusions: drug coated balloons in SFA lesions. J Cardiovasc Surg (Torino). 2012 Aug;53(4):481-6.
- Background: PubMed 21751121Schmidt W, Wissgott C, Andresen R, Behrens P, Schmitz KP. Performance characteristics of modern self-expanding nitinol stents indicated for SFA. Rofo. 2011 Sep;183(9):818-25. doi: 10.1055/s-0031-1273445. Epub 2011 Jul 12.
- Background: PubMed 20717726Johnston CR, Lee K, Flewitt J, Moore R, Dobson GM, Thornton GM. The mechanical properties of endovascular stents: an in vitro assessment. Cardiovasc Eng. 2010 Sep;10(3):128-35. doi: 10.1007/s10558-010-9097-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsar Stent and LifeStent Flexstar Vascular Stent in people with Stent Restenosis and Intimal Hyperplasia, run by Medical University of Vienna at 1 site in Austria.
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 17 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
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?
Amount of in-stent restenosis (time frame: one and two years post-procedure). 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 NCT03097679, which also lists 21 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 20 Feb 2020.