Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease

NCT02544555 | Unknown DMC

• 1 other identifier: SCENARIO-FP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Peripheral Arterial Disease; Atherosclerosis

Keywords

Peripheral arterial disease; Atherosclerosis; Intraluminal approach; Subintimal approach

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Secondary Outcomes (13)

• Limb salvage rate free of above-the-ankle amputation.

  One year

• Sustained clinical improvement rate.

  One year

• Repeated target lesion revascularization (TLR) rate.

  One year

• Repeated target extremity revascularization (TER) rate.

  One year

• Total reocclusion rate.

  One year

Study Arms (2)

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.

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.

Procedure: Intentional subintimal approach

Interventions

Intentional intraluminal approach PROCEDURE

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 intraluminal approach

Intentional subintimal approach PROCEDURE

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.

Intentional subintimal approach

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (3)

Cardiovascular center, Korea University Guro Hospital

Seoul, 152-703, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 152-703, South Korea

RECRUITING

Seung Woon Rha

Seoul, South Korea

RECRUITING

Related Publications (15)

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  PMID: 18540697 BACKGROUND

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  PMID: 23910456 BACKGROUND

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  PMID: 21430937 BACKGROUND

• Kidd 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

• 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.

  PMID: 12563211 BACKGROUND

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  PMID: 9308598 BACKGROUND

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  PMID: 17317699 BACKGROUND

• Duda 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.

  PMID: 12234956 BACKGROUND

• Vollmar J (1975) Rekonstruktive Chirurgie der Arterien. Georg Thieme Verlag, Stuttgart, pp 265-266.

  BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Seung-Woon Rha, MD, PhD

  Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Woon Rha, MD, PhD

CONTACT

82-2-818-6387; swrha617@yahoo.co.kr

Sang-Ho Park, MD, PhD

CONTACT

82-41-570-3670; matsalong@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 9, 2015
• Study Start: May 1, 2014
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

KR (3)