Clinical trial NCT02544555: Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease
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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Atherosclerosis
Keywords: Peripheral arterial disease
Atherosclerosis
Intraluminal approach
Subintimal approach
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The rate of binary restenosis.
timeFrame: One year
Secondary outcomes:
measure: Limb salvage rate free of above-the-ankle amputation.
timeFrame: One year
measure: Sustained clinical improvement rate.
timeFrame: One year
measure: Repeated target lesion revascularization (TLR) rate.
timeFrame: One year
measure: Repeated target extremity revascularization (TER) rate.
timeFrame: One year
measure: Total reocclusion rate.
timeFrame: One year
measure: Comparison of late angiographic restenosis (%).
timeFrame: One year
measure: Ankle-brachial index (ABI).
timeFrame: One year
measure: The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction and stroke.
timeFrame: One year
measure: The duration of the procedure from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
timeFrame: One year
measure: The amount of contrast from just before the guidewire enters the lesion, to when it proceeds into the distal normal vessel
timeFrame: One year
measure: The length of distal normal vessel's injury related to the guidewire or re-entry device.
timeFrame: One year
measure: Incidence of vascular perforation with the failure rate of procedure.
timeFrame: One year
measure: Death rate related to procedure.
timeFrame: One year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiovascular center, Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seung Woon Rha
Study officials:
affiliation: Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, South Korea
name: Seung-Woon Rha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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