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

Critical Limb Ischemia Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644487
• Other study ID #: EV-10302
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: October 10, 2018

Study information

• Verified date: August 2017
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 10, 2018
• Est. primary completion date: September 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Critical Limb Ischemia
• Infrapopliteal Arterial Occlusive Disease
• Ischemia

Intervention

Device:
• self-expanding nitinol stent
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
• balloon angioplasty
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic binary restenosis rate		12 months