Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease

Atherosclerosis Clinical Trial

Official title:

Phase 4 Study of Efficacy of Balloon-Expandable Cobalt Chromium SCUBA Stent Versus Self-Expandable Stent COMPLETE-SE Nitinol Stenting for the Atherosclerotic ILIAC Arterial Disease: Prospective, Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834495
• Other study ID #: SENS-ILIAC
• Status: Completed
• Phase: N/A
• Start date: October 28, 2012
• Est. completion date: February 11, 2019

Study information

• Verified date: August 2018
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the investigators study is to examine and compare primary patency between balloon expandable cobalt chromium stent and self expandable nitinol stents (SCUBA versus COMPLETE-SE) in atherosclerotic iliac artery lesion.

Description:

Obstructive atherosclerotic disease of the distal aorta and iliac arteries is preferentially treated with endovascular techniques, and an endovascular-first strategy can be recommended for all TransAtlantic Inter-Society Consensus (TASC) A-C lesions. Low morbidity and mortality as well as a >90% technical success rate justify the endovascular-first approach. Currently, In an attempt to improve outcomes, stent use has increased, and a number of studies favor iliac stenting over simple Percutaneous Transluminal Angioplasty (PTA). A meta-analysis comparing iliac stenting to Percutaneous Transluminal Angioplasty (PTA) found that stenting had higher rates of technical success and was associated with a 39% reduction in the risk of long-term loss of patency.

However, randomized control trial for comparison of primary patency between balloon expandable stent and self expandable stent has not been done, although there were some trials in that primary patency was compared among balloon expandable stents or among self expandable stents.

Currently, The choice of balloon versus self expandable stents is determined mainly by operator preference. The main advantages of balloon expandable stents are the higher radial stiffness and the more accurate placement, which is especially important in bifurcation lesions. In the external iliac artery, a primary stenting strategy using self-expandable stents compared with provisional stenting is preferred mainly due to a lower risk of dissection and elastic recoil.

Thus, the purpose of our study is to examine and compare primary patency between balloon expandable stent and self expandable stent(SCUBA versus COMPLETE SE stent)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: February 11, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1.Clinical criteria:

1. symptomatic peripheral-artery disease with

• moderate to severe claudication (Rutherford 2-3),

• chronic critical limb ischemia with pain while was at rest (Rutherford 4),

• or chronic critical limb ischemia with ischemic ulcers (Rutherford 5-6)

2. Patients with signed informed consent

2. Anatomical criteria:

1. Target lesion length = 4 cm by angiographic estimation,

2. Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,

3. Patent (=50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (=30% residual stenosis),

4. At least one patent (less than 50% stenosed) tibioperoneal runoff vessel.

Exclusion Criteria:

1. Disagree with written informed consent

2. Major bleeding history within prior 2 months

3. Known hypersensitivity or contraindication to any of the following medications:

heparin, aspirin, clopidogrel or contrast agent

4. Acute limb ischemia

5. Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion)

6. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required

7. Patients with life expectancy <1 year due to comorbidity

8. Age > 85 years

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Balloon expandable stent
provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
• Self expandable stent
provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection

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	Primary patency rate	stenosis of at least 50 percent of the luminal diameter in the treated segment 12 months after intervention, as determined by quantitative angiography or CT angiography or peak systolic velocity ratio >2.5 by duplex sonography according to the stent type	1year
Secondary	Clinical outcome	Limb salvage (free of above-the-ankle amputation)	1 year
Secondary	Clinical outcome	Sustained clinical improvement rate at 12 month follow-up	1 year
Secondary	Clinical outcome	Ankle-brachial index (ABI) at 12 months	1 year
Secondary	Clinical outcome	The rate of major adverse cardiovascular events (MACE) at 12 months	1 year
Secondary	Clinical outcome	Repeated target lesion revascularization (TLR) rate	1year
Secondary	Angiographic outcome	Stent fracture rate	1 year
Secondary	Angiographic outcome	Incidence of geographic miss	1 year
Secondary	Clinical outcome	Repeated target extremity revascularization (TER) rate	1 year