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

Primary Purpose

Peripheral Arterial Disease, Atherosclerosis

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Intentional intraluminal approach

Intentional subintimal approach

Sponsored by

Korea University Guro Hospital

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Atherosclerosis, Intraluminal approach, Subintimal approach

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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.

Sites / Locations

Cardiovascular center, Korea University Guro HospitalRecruiting
Korea University Guro HospitalRecruiting
Seung Woon RhaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intentional intraluminal approach

Intentional subintimal approach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Sustained clinical improvement rate.

Repeated target lesion revascularization (TLR) rate.

Repeated target extremity revascularization (TER) rate.

Total reocclusion rate.

Comparison of late angiographic restenosis (%).

Ankle-brachial index (ABI).

The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke.

The duration of the procedure from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel

The amount of contrast from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel

The length of distal normal vessel's injury related to the guidewire or re-entry device.

Incidence of vascular perforation with the failure rate of procedure.

Death rate related to procedure.

Full Information

NCT ID

First Posted

August 27, 2015

Last Updated

August 31, 2020

Sponsor

Korea University Guro Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02544555

Brief Title

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

Acronym

SCENARIO-FP

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (Actual)

Primary Completion Date

May 31, 2021 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University Guro Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Atherosclerosis

Keywords

Peripheral arterial disease, Atherosclerosis, Intraluminal approach, Subintimal approach

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intentional intraluminal approach

Arm Type

Experimental

Arm Description

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.

Arm Title

Intentional subintimal approach

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intentional intraluminal approach

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intentional subintimal approach

Intervention Description

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 Measure Information:

Title

The rate of binary restenosis.

Description

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.

Time Frame

One year

Secondary Outcome Measure Information:

Title

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

Time Frame

One year

Title

Sustained clinical improvement rate.

Time Frame

One year

Title

Repeated target lesion revascularization (TLR) rate.

Time Frame

One year

Title

Repeated target extremity revascularization (TER) rate.

Time Frame

One year

Title

Total reocclusion rate.

Time Frame

One year

Title

Comparison of late angiographic restenosis (%).

Time Frame

One year

Title

Ankle-brachial index (ABI).

Time Frame

One year

Title

The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke.

Time Frame

One year

Title

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

Title

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

Title

The length of distal normal vessel's injury related to the guidewire or re-entry device.

Time Frame

One year

Title

Incidence of vascular perforation with the failure rate of procedure.

Time Frame

One year

Title

Death rate related to procedure.

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seung-Woon Rha, MD, PhD

Phone

82-2-818-6387

Email

swrha617@yahoo.co.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Sang-Ho Park, MD, PhD

Phone

82-41-570-3670

Email

matsalong@schmc.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung-Woon Rha, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiovascular center, Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung-Woon Rha, MD, PhD

Phone

82-2-818-6387

Email

swrha617@yahoo.co.kr

First Name & Middle Initial & Last Name & Degree

Seung-Woon Rha, MD, PhD

Facility Name

Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung Woon Rha, MD, PhD

Phone

82-2-818-6387

Email

swrha617@yahoo.co.kr

First Name & Middle Initial & Last Name & Degree

Sang Ho Park, MD, PhD

Phone

82-41-570-3670

Email

matsalong@schmc.ac.kr

First Name & Middle Initial & Last Name & Degree

Seung Woon Rha, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sang Ho Park, MD, PhD

Facility Name

Seung Woon Rha

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seung Woon Rha, MD,PhD

Phone

82-2626-3020

Email

swrha@yahoo.co.kr

First Name & Middle Initial & Last Name & Degree

Seung Woon Rha, MD,PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

2149672

Citation

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

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