Clinical trial NCT01644487: Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Infrapopliteal Arterial Occlusive Disease
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Angiographic binary restenosis rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: