Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease (SCENARIO-FP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544555
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Atherosclerosis Procedure: Intentional intraluminal approach Procedure: Intentional subintimal approach Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Experimental: Intentional intraluminal approach
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
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.

Active Comparator: Intentional subintimal approach
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Limb salvage rate free of above-the-ankle amputation. [ Time Frame: One year ]
  2. Sustained clinical improvement rate. [ Time Frame: One year ]
  3. Repeated target lesion revascularization (TLR) rate. [ Time Frame: One year ]
  4. Repeated target extremity revascularization (TER) rate. [ Time Frame: One year ]
  5. Total reocclusion rate. [ Time Frame: One year ]
  6. Comparison of late angiographic restenosis (%). [ Time Frame: One year ]
  7. Ankle-brachial index (ABI). [ Time Frame: One year ]
  8. The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke. [ Time Frame: One year ]
  9. 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 ]
  10. 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 ]
  11. The length of distal normal vessel's injury related to the guidewire or re-entry device. [ Time Frame: One year ]
  12. Incidence of vascular perforation with the failure rate of procedure. [ Time Frame: One year ]
  13. Death rate related to procedure. [ Time Frame: One year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical Criteria

    1. Age 20 years of older
    2. 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)
    3. Patients with signed informed consent
  • Anatomical Criteria

    1. Chronic occlusive lesion in coronary angiography
    2. Stenosis of <50% atherosclerotic lesion of the ipsilateral femoropopliteal artery
    3. Residual stenosis of <50% atherosclerotic lesion of the ipsilateral femoro-popliteal artery after treatment for >50% of the lesion.
    4. 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.
    5. 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.

Exclusion Criteria:

  1. Under 20 years-old or over 85 years-old.
  2. Disagree with written informed consent
  3. Major bleeding history within prior 2 months
  4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agent
  5. Acute limb ischemia
  6. Previous bypass surgery or stenting of the ipsilateral femoro-popliteal artery
  7. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
  8. Patients with major amputation ("above the ankle" amputation) which has been done, is planned or required
  9. Patients with life expectancy <1 year due to comorbidity
  10. Severe medical or surgical illness limit participating study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544555


Contacts
Layout table for location contacts
Contact: Seung-Woon Rha, MD, PhD 82-2-818-6387 swrha617@yahoo.co.kr
Contact: Sang-Ho Park, MD, PhD 82-41-570-3670 matsalong@schmc.ac.kr

Locations
Layout table for location information
Korea, Republic of
Cardiovascular center, Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Seung-Woon Rha, MD, PhD    82-2-818-6387    swrha617@yahoo.co.kr   
Principal Investigator: Seung-Woon Rha, MD, PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Seung Woon Rha, MD, PhD    82-2-818-6387    swrha617@yahoo.co.kr   
Contact: Sang Ho Park, MD, PhD    82-41-570-3670    matsalong@schmc.ac.kr   
Principal Investigator: Seung Woon Rha, MD, PhD         
Sub-Investigator: Sang Ho Park, MD, PhD         
Seung Woon Rha Recruiting
Seoul, Korea, Republic of
Contact: Seung Woon Rha, MD,PhD    82-2626-3020    swrha@yahoo.co.kr   
Principal Investigator: Seung Woon Rha, MD,PhD         
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Layout table for investigator information
Principal Investigator: Seung-Woon Rha, MD, PhD Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea

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

Layout table for additonal information
Responsible Party: Seung Woon Rha, Clinical Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT02544555     History of Changes
Other Study ID Numbers: SCENARIO-FP
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Seung Woon Rha, Korea University Guro Hospital:
Peripheral arterial disease
Atherosclerosis
Intraluminal approach
Subintimal approach
Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases