Peripheral Arterial DiseaseSCENARIO-FPNCT02544555
Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease
A study testing Intentional intraluminal approach and Intentional subintimal approach in people with Peripheral Arterial Disease and Atherosclerosis, run by Korea University Guro Hospital at 3 sites in South Korea.
Trial summary
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal approach of passing wire through the subintima of the vessel. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Atherosclerosis
- What is being tested?
- Intentional intraluminal approach and Intentional subintimal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2014to 31 May 2022
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical Criteria
- Age 20 years of older
- Symptomatic peripheral-artery disease with (Rutherford 2 - 6); moderate to severe claudication (Rutherford 2-3), chronic critical limb ischemia with pain while at rest (Rutherford 4), or with ischemic ulcers (Rutherford 5-6)
- Patients with signed informed consent
- Anatomical Criteria
- Chronic occlusive lesion in coronary angiography
Show all 10Show fewer
- Stenosis of <50% atherosclerotic lesion of the ipsilateral femoropopliteal artery
- Residual stenosis of <50% atherosclerotic lesion of the ipsilateral femoro-popliteal artery after treatment for >50% of the lesion.
- Patent (≤50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (≤30% residual stenosis), At least one patent (less than 50% stenosed) tibioperoneal run-off vessel.
- Only balloon angioplasty can be performed for popliteal arterial lesion, however if suboptimal or bailout result is expected with sole balloon angioplasty, stent placement is allowed. Bailout or suboptimal result is defined as SFA lesion.
Who cannot join
- Under 20 years-old or over 85 years-old.
- Disagree with written informed consent
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agent
- Acute limb ischemia
- Previous bypass surgery or stenting of the ipsilateral femoro-popliteal artery
Show all 10Show fewer
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
- Patients with major amputation ("above the ankle" amputation) which has been done, is planned or required
- Patients with life expectancy <1 year due to comorbidity
- Severe medical or surgical illness limit participating study.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Cardiovascular center, Korea University Guro Hospital
Seoul, 152-703
Seung-Woon Rha, MD, PhD, 82-2-818-6387, swrha617@yahoo.co.kr
Seung-Woon Rha, MD, PhD
- Recruiting
Korea University Guro Hospital
Seoul, 152-703
Seung Woon Rha, MD, PhD, 82-2-818-6387, swrha617@yahoo.co.kr
Sang Ho Park, MD, PhD, 82-41-570-3670, matsalong@schmc.ac.kr
- Recruiting
Seung Woon Rha
Seoul
Seung Woon Rha, MD,PhD, 82-2626-3020, swrha@yahoo.co.kr
Seung Woon Rha, MD,PhD
About this study
Official title: Safety and Efficacy of Subintimal Versus Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoro-Popliteal Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial (SCENARIO-FP)
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal approach of passing wire through the subintima of the vessel.
Either of these two interventional technique can be chosen depending on the character of the lesions they have their own pros and cons which affects the success of the intervention. The study is limited to retrospective studies to which interventional technique is better for post-procedural recurrence rate, however there is no prospective randomized controlled study.
Read the detailed description
During interventions for atherosclerotic femoro-popliteal arterial lesion, chronic occlusive lesions are commonly encountered. The decision to approach these lesions by either guide wire, intraluminal approach or subintimal approach is by the decision of the operator. The subintimal approach intentionally passes the guide wire through the subintimal layer of vessel which was developed by Dr. Bolia. Through the subintimal approach, the success rate of procedure has increased. However this technique has shown some limitations which are guide wire re-entry, intimal injury, lengthening of the original lesion, periadventitial hematoma, perforated vessel, collateral vascular occlusion and limited usage of atherectomy devices.
On the contrary, intimal approach is not only able to overcome the limitations of the subintimal approach, but it has shown an advantage in improving the success rate of the procedure by the variable techniques of anterograde, retrograde and trans-collaterals approach. These techniques however usually require longer procedure time with more exposure to larger amounts of intravenous contrast and radiation. It often cause the need for more interventional devices which results in higher expense such that it is a less cost-effective method.
Recently the recommendation is the combination of these 2 interventional techniques depending on the character of lesions. As above, these approaches are chosen depending on the character of the lesion, however there are only limited retrospective studies without prospective randomized controlled study present to decide which method is better in terms of post-procedural recurrence rate.
- Conditions
- Peripheral Arterial Disease, Atherosclerosis
- Being tested
- Intentional intraluminal approach, Intentional subintimal approach
- Keywords
- Peripheral arterial disease, Atherosclerosis, Intraluminal approach, Subintimal approach
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intentional intraluminal approachProcedure or surgery
Interventionist performs intentional intraluminal approach to angioplasty. Dedicated 018 and 014 guidewire for Chronic Total Occlusion (CTO) lesion and Chronic Total Occlusion (CTO) devices such as Truepath or Frontrunner can be chosen by interventionist. Methods to confirm successful intraluminal wiring will be selected, as follows; 1) examination for guidewire position in different two angles on fluoroscopy or 2) intravascular ultrasound (IVUS) exam after predilation is performed with an appropriately sized angioplasty balloon. After the guidewire is passed through the lumen of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed, if the case that optimal ballooning response is not obtained.
Intentional subintimal approachProcedure or surgery
Interventionist performs Intentional subintimal approach to angioplasty. 035 Terumo guidewires will be used. If 035 Terumo guidewire is not able to re-entry, Re-entry devices such as Offroad or OUTBACK catheter can be used. After the guidewire is passed through the subintimal layer of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed; the case that optimal ballooning response is not obtained should be enrolled. The sub-optimal balloon response is defined as a residual pressure gradient of >15 mmHg, residual stenosis of >30%, and flow-limiting dissection.
| Study group | Role | What they receive |
|---|---|---|
| Intentional intraluminal approach | Experimental | Intentional intraluminal approach is the way that the passage of guidewire in chronic total occlusive femoro-popliteal arterial lesion is performed via intraluminal route using various intraluminal devices. in an intraluminal approach, the response to the balloon is more favorable, but the outcome depends on the experience of the surgeon, and the approach requires more time and is more costly. Receives: Procedure: Intentional intraluminal approach |
| Intentional subintimal approach | Active comparator | Intentional subintimal approach is the method that recanalization is performed via subintimal route with a 0.035-inch looped guidewire and a supporting catheter at the occlusion site. Due to its simplicity and low cost, this approach has been used for many patients with femoropopliteal occlusion. Receives: Procedure: Intentional subintimal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of binary restenosis.
the rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) or PSVR ≥ 2.5 or zero (PSVR=peak systolic velocity within the area of stenosis divided by peak systolic velocity in a normal adjacent proximal artery segment) in the treated segment at 12 months after intervention as determined by catheter angiography or Duplex ultrasound.
Measured: One year
Secondary outcomes (13)
Limb salvage rate free of above-the-ankle amputation.
Measured: One year
Sustained clinical improvement rate.
Measured: One year
Repeated target lesion revascularization (TLR) rate.
Measured: One year
Repeated target extremity revascularization (TER) rate.
Measured: One year
Total reocclusion rate.
Measured: One year
Comparison of late angiographic restenosis (%).
Measured: One year
Ankle-brachial index (ABI).
Measured: One year
The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke.
Measured: One year
The duration of the procedure from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
Measured: One year
The amount of contrast from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
Measured: One year
The length of distal normal vessel's injury related to the guidewire or re-entry device.
Measured: One year
Incidence of vascular perforation with the failure rate of procedure.
Measured: One year
Death rate related to procedure.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startMay 2014
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Woon Rha, Korea University Guro Hospital
- Investigators
- Seung-Woon Rha, MD, PhD, Principal investigator, Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544555
- Sponsor's protocol ID
- SCENARIO-FP
- Acronym
- SCENARIO-FP
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol. 1990 Dec;13(6):357-63. doi: 10.1007/BF02578675.
PubMed 2149672Noory E, Rastan A, Sixt S, Schwarzwalder U, Leppannen O, Schwarz T, Burgelin K, Hauk M, Branzan D, Hauswald K, Beschorner U, Nazary T, Brantner R, Neumann FJ, Zeller T. Arterial puncture closure using a clip device after transpopliteal retrograde approach for recanalization of the superficial femoral artery. J Endovasc Ther. 2008 Jun;15(3):310-4. doi: 10.1583/07-2324.1.
PubMed 18540697Montero-Baker M, Schmidt A, Braunlich S, Ulrich M, Thieme M, Biamino G, Botsios S, Bausback Y, Scheinert D. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther. 2008 Oct;15(5):594-604. doi: 10.1583/08-2440.1.
PubMed 18840044Bosiers M, Deloose K, Callaert J, Maene L, Keirse K, Verbist J, Peeters P. In lower extremity PTAs intraluminal is better than subintimal. J Cardiovasc Surg (Torino). 2012 Apr;53(2):223-7.
PubMed 22456645Soga Y, Iida O, Suzuki K, Hirano K, Kawasaki D, Shintani Y, Suematsu N, Yamaoka T. Initial and 3-year results after subintimal versus intraluminal approach for long femoropopliteal occlusion treated with a self-expandable nitinol stent. J Vasc Surg. 2013 Dec;58(6):1547-55. doi: 10.1016/j.jvs.2013.05.107. Epub 2013 Aug 1.
PubMed 23910456Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
PubMed 20484101Strecker EP, Boos IB, Gottmann D, Vetter S, Haase W. Popliteal artery stenting using flexible tantalum stents. Cardiovasc Intervent Radiol. 2001 May-Jun;24(3):168-75. doi: 10.1007/s002700002526.
PubMed 11443404Chang IS, Chee HK, Park SW, Yun IJ, Hwang JJ, Lee SA, Kim JS, Chang SH, Jung HG. The primary patency and fracture rates of self-expandable nitinol stents placed in the popliteal arteries, especially in the P2 and P3 segments, in Korean patients. Korean J Radiol. 2011 Mar-Apr;12(2):203-9. doi: 10.3348/kjr.2011.12.2.203. Epub 2011 Mar 3.
PubMed 21430937Kidd J, Bourke BM, Dunwoodie J et al. The role of pre and postprocedural color Duplex ultrasound for the treatment of lower limb ischemia by subintimal angioplasty. J Vasc Ultrasound. 2006;30:17-21.
Lipsitz EC, Ohki T, Veith FJ, Suggs WD, Wain RA, Cynamon J, Mehta M, Cayne N, Gargiulo N. Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia? J Vasc Surg. 2003 Feb;37(2):386-91. doi: 10.1067/mva.2003.20.
PubMed 12563211London NJ, Srinivasan R, Naylor AR, Hartshorne T, Ratliff DA, Bell PR, Bolia A. Reprinted article "Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results". Eur J Vasc Endovasc Surg. 2011 Sep;42 Suppl 1:S9-15. doi: 10.1016/j.ejvs.2011.06.018.
PubMed 21855032Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
PubMed 9308598Diehm N, Baumgartner I, Jaff M, Do DD, Minar E, Schmidli J, Diehm C, Biamino G, Vermassen F, Scheinert D, van Sambeek MR, Schillinger M. A call for uniform reporting standards in studies assessing endovascular treatment for chronic ischaemia of lower limb arteries. Eur Heart J. 2007 Apr;28(7):798-805. doi: 10.1093/eurheartj/ehl545. Epub 2007 Feb 22.
PubMed 17317699Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A, Wiesinger B, Hak JB, Tielemans H, Ziemer G, Cristea E, Lansky A, Beregi JP. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation. 2002 Sep 17;106(12):1505-9. doi: 10.1161/01.cir.0000029746.10018.36.
PubMed 12234956Vollmar J (1975) Rekonstruktive Chirurgie der Arterien. Georg Thieme Verlag, Stuttgart, pp 265-266.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Subintimal Versus Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoro-Popliteal Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial (SCENARIO-FP)
- ClinicalTrials.gov ID
- NCT02544555
- Acronym / sponsor ID
- SCENARIO-FP / SCENARIO-FP
- Conditions
- Peripheral Arterial Disease, Atherosclerosis
- Keywords
- Peripheral arterial disease, Atherosclerosis, Intraluminal approach, Subintimal approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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.
There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal approach of passing wire through the subintima of the vessel.
Either of these two interventional technique can be chosen depending on the character of the lesions they have their own pros and cons which affects the success of the intervention. The study is limited to retrospective studies to which interventional technique is better for post-procedural recurrence rate, however there is no prospective randomized controlled study.
Detailed description
During interventions for atherosclerotic femoro-popliteal arterial lesion, chronic occlusive lesions are commonly encountered. The decision to approach these lesions by either guide wire, intraluminal approach or subintimal approach is by the decision of the operator. The subintimal approach intentionally passes the guide wire through the subintimal layer of vessel which was developed by Dr. Bolia. Through the subintimal approach, the success rate of procedure has increased. However this technique has shown some limitations which are guide wire re-entry, intimal injury, lengthening of the original lesion, periadventitial hematoma, perforated vessel, collateral vascular occlusion and limited usage of atherectomy devices.
On the contrary, intimal approach is not only able to overcome the limitations of the subintimal approach, but it has shown an advantage in improving the success rate of the procedure by the variable techniques of anterograde, retrograde and trans-collaterals approach. These techniques however usually require longer procedure time with more exposure to larger amounts of intravenous contrast and radiation. It often cause the need for more interventional devices which results in higher expense such that it is a less cost-effective method.
Recently the recommendation is the combination of these 2 interventional techniques depending on the character of lesions. As above, these approaches are chosen depending on the character of the lesion, however there are only limited retrospective studies without prospective randomized controlled study present to decide which method is better in terms of post-procedural recurrence rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intentional intraluminal approach | Experimental | Procedure: Intentional intraluminal approachIntentional intraluminal approach is the way that the passage of guidewire in chronic total occlusive femoro-popliteal arterial lesion is performed via intraluminal route using various intraluminal devices. in an intraluminal approach, the response to the balloon is more favorable, but the outcome depends on the experience of the surgeon, and the approach requires more time and is more costly. |
| Intentional subintimal approach | Active comparator | Procedure: Intentional subintimal approachIntentional subintimal approach is the method that recanalization is performed via subintimal route with a 0.035-inch looped guidewire and a supporting catheter at the occlusion site. Due to its simplicity and low cost, this approach has been used for many patients with femoropopliteal occlusion. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical Criteria
- Anatomical Criteria
Key exclusion criteria (10 listed)
- Under 20 years-old or over 85 years-old.
- Disagree with written informed consent
- Major bleeding history within prior 2 months
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agent
- Acute limb ischemia
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 |
|---|---|---|
| Intentional intraluminal approachInterventionist performs intentional intraluminal approach to angioplasty. Dedicated 018 and 014 guidewire for Chronic Total Occlusion (CTO) lesion and Chronic Total Occlusion (CTO) devices such as Truepath or Frontrunner can be chosen by interventionist. Methods to confirm successful intraluminal wiring will be selected, as follows; 1) examination for guidewire position in different two angles on fluoroscopy or 2) intravascular ultrasound (IVUS) exam after predilation is performed with an appropriately sized angioplasty balloon. After the guidewire is passed through the lumen of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed, if the case that optimal ballooning response is not obtained. | Procedure or surgery | Intentional intraluminal approach |
| Intentional subintimal approachInterventionist performs Intentional subintimal approach to angioplasty. 035 Terumo guidewires will be used. If 035 Terumo guidewire is not able to re-entry, Re-entry devices such as Offroad or OUTBACK catheter can be used. After the guidewire is passed through the subintimal layer of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed; the case that optimal ballooning response is not obtained should be enrolled. The sub-optimal balloon response is defined as a residual pressure gradient of >15 mmHg, residual stenosis of >30%, and flow-limiting dissection. | Procedure or surgery | Intentional subintimal approach |
Primary outcome
The rate of binary restenosis.
Time frame: One year
the rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) or PSVR ≥ 2.5 or zero (PSVR=peak systolic velocity within the area of stenosis divided by peak systolic velocity in a normal adjacent proximal artery segment) in the treated segment at 12 months after intervention as determined by catheter angiography or Duplex ultrasound.
13 secondary outcomes
Limb salvage rate free of above-the-ankle amputation.
Time frame: One year
Sustained clinical improvement rate.
Time frame: One year
Repeated target lesion revascularization (TLR) rate.
Time frame: One year
Repeated target extremity revascularization (TER) rate.
Time frame: One year
Total reocclusion rate.
Time frame: One year
Comparison of late angiographic restenosis (%).
Time frame: One year
Ankle-brachial index (ABI).
Time frame: One year
The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke.
Time frame: One year
The duration of the procedure from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
Time frame: One year
The amount of contrast from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
Time frame: One year
The length of distal normal vessel's injury related to the guidewire or re-entry device.
Time frame: One year
Incidence of vascular perforation with the failure rate of procedure.
Time frame: One year
Death rate related to procedure.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 2149672Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol. 1990 Dec;13(6):357-63. doi: 10.1007/BF02578675.
- Background: PubMed 18540697Noory E, Rastan A, Sixt S, Schwarzwalder U, Leppannen O, Schwarz T, Burgelin K, Hauk M, Branzan D, Hauswald K, Beschorner U, Nazary T, Brantner R, Neumann FJ, Zeller T. Arterial puncture closure using a clip device after transpopliteal retrograde approach for recanalization of the superficial femoral artery. J Endovasc Ther. 2008 Jun;15(3):310-4. doi: 10.1583/07-2324.1.
- Background: PubMed 18840044Montero-Baker M, Schmidt A, Braunlich S, Ulrich M, Thieme M, Biamino G, Botsios S, Bausback Y, Scheinert D. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther. 2008 Oct;15(5):594-604. doi: 10.1583/08-2440.1.
- Background: PubMed 22456645Bosiers M, Deloose K, Callaert J, Maene L, Keirse K, Verbist J, Peeters P. In lower extremity PTAs intraluminal is better than subintimal. J Cardiovasc Surg (Torino). 2012 Apr;53(2):223-7.
- Background: PubMed 23910456Soga Y, Iida O, Suzuki K, Hirano K, Kawasaki D, Shintani Y, Suematsu N, Yamaoka T. Initial and 3-year results after subintimal versus intraluminal approach for long femoropopliteal occlusion treated with a self-expandable nitinol stent. J Vasc Surg. 2013 Dec;58(6):1547-55. doi: 10.1016/j.jvs.2013.05.107. Epub 2013 Aug 1.
- Background: PubMed 20484101Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
- Background: PubMed 11443404Strecker EP, Boos IB, Gottmann D, Vetter S, Haase W. Popliteal artery stenting using flexible tantalum stents. Cardiovasc Intervent Radiol. 2001 May-Jun;24(3):168-75. doi: 10.1007/s002700002526.
- Background: PubMed 21430937Chang IS, Chee HK, Park SW, Yun IJ, Hwang JJ, Lee SA, Kim JS, Chang SH, Jung HG. The primary patency and fracture rates of self-expandable nitinol stents placed in the popliteal arteries, especially in the P2 and P3 segments, in Korean patients. Korean J Radiol. 2011 Mar-Apr;12(2):203-9. doi: 10.3348/kjr.2011.12.2.203. Epub 2011 Mar 3.
- BackgroundKidd J, Bourke BM, Dunwoodie J et al. The role of pre and postprocedural color Duplex ultrasound for the treatment of lower limb ischemia by subintimal angioplasty. J Vasc Ultrasound. 2006;30:17-21.
- Background: PubMed 12563211Lipsitz EC, Ohki T, Veith FJ, Suggs WD, Wain RA, Cynamon J, Mehta M, Cayne N, Gargiulo N. Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia? J Vasc Surg. 2003 Feb;37(2):386-91. doi: 10.1067/mva.2003.20.
- Background: PubMed 21855032London NJ, Srinivasan R, Naylor AR, Hartshorne T, Ratliff DA, Bell PR, Bolia A. Reprinted article "Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results". Eur J Vasc Endovasc Surg. 2011 Sep;42 Suppl 1:S9-15. doi: 10.1016/j.ejvs.2011.06.018.
- Background: PubMed 9308598Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Seung-Woon Rha, MD, PhD principal investigator
Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intentional intraluminal approach and Intentional subintimal approach in people with Peripheral Arterial Disease and Atherosclerosis, run by Korea University Guro Hospital at 3 sites in South Korea.
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 10 inclusion and 10 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Contact Seung-Woon Rha, MD, PhD (82-2-818-6387, swrha617@yahoo.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of binary restenosis. (time frame: One year). 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 NCT02544555, which also lists 15 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 2 Sep 2020.