Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries. Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.

Official Title
-----------------
Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)

Conditions
-----------------
Critical Limb Ischemia, Infrapopliteal Arterial Occlusive Disease

Intervention / Treatment
-----------------
* Device: self-expanding nitinol stent
* Device: balloon angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic critical limb ischemia (Rutherford 4 - 6) Patients with signed informed consent Target lesion length < 8 cm by angiographic estimation Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery Reference vessel diameter should be 2.0-4.5 mm Exclusion Criteria: Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies Patient takes warfarin Patient has a history of previous life-threatening contrast media reaction Patient is currently enrolled in another investigational device or drug trial Patient is currently breast-feeding, is pregnant, or intends to become pregnant Patient is mentally ill or retarded Acute critical limb ischemia Major bleeding history within prior 2 months Severe hepatic dysfunction (> 3 times normal reference values) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis Life expectancy <1 year due to comorbidity Reference segment diameter is not suitable for available stent design Previously implanted stent(s) or PTA at the same lesion site Inflow-limiting arterial lesions left untreated

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary stenting<br>A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty | Device: self-expanding nitinol stent<br>* A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty<br>* Other names: Xpert stent;|
| Active Comparator: Balloon only<br>A group of patients who will undergo routine conventional balloon angioplasty alone without stenting | Device: balloon angioplasty<br>* A group of patients who will undergo routine conventional balloon angioplasty alone without stenting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic binary restenosis rate |  | 12 months |