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

NCT01644487 | Completed

• 1 other identifier: EV-10302
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Angiographic binary restenosis rate

  12 months

Study Arms (2)

Primary stenting

EXPERIMENTAL

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

Device: self-expanding nitinol stent

Balloon only

ACTIVE COMPARATOR

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

Device: balloon angioplasty

Interventions

self-expanding nitinol stent DEVICE

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

Also known as: Xpert stent

Primary stenting

balloon angioplasty DEVICE

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

Balloon only

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: July 1, 2012
• Primary Completion: September 6, 2016
• Study Completion: October 10, 2018
• Last Updated: August 14, 2019

Record last verified: 2017-08

Locations

KR (1)