Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease (SCENARIO-FP)
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|ClinicalTrials.gov Identifier: NCT02544555|
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : August 14, 2019
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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 ]
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
|Contact: Seung-Woon Rha, MD, PhDfirstname.lastname@example.org|
|Contact: Sang-Ho Park, MD, PhDemail@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Sang Ho Park, MD, PhD 82-41-570-3670 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Seung Woon Rha, MD,PhD|
|Principal Investigator:||Seung-Woon Rha, MD, PhD||Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea|