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

NCT ID: NCT01644487

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2018-10-10

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.

Conditions

Critical Limb Ischemia; Infrapopliteal Arterial Occlusive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary stenting

A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty

Group Type: EXPERIMENTAL

self-expanding nitinol stent

Intervention Type: DEVICE

A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty

Balloon only

A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Group Type: ACTIVE_COMPARATOR

balloon angioplasty

Intervention Type: DEVICE

A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Interventions

self-expanding nitinol stent

A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty

Intervention Type: DEVICE

balloon angioplasty

A group of patients who will undergo routine conventional balloon angioplasty alone without stenting

Intervention Type: DEVICE

Other Intervention Names

Xpert stent

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung Woon Rha

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

EV-10302

Identifier Type: -

Identifier Source: org_study_id