NCT01644487

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia
• Infrapopliteal Arterial Occlusive Disease

Interventions

Type	Name	Description
DEVICE	self-expanding nitinol stent	A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
DEVICE	balloon angioplasty	A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-09-06
• Completion: 2018-10-10
• First posted: 2012-07-19
• Last updated: 2019-08-14

Locations

1 site across 1 country: South Korea