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

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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Peripheral Artery Disease
• Intervention / Treatment: Device: Balloon expandable stent; Device: Self expandable stent

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon expandable stent; study design is 1:1 randomization design. Patients will be randomized in a 1:1 manner according to different two (balloon expandable versus Self expandable)stents. Randomization procedure will be performed using a web-based program	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; Other Names: SCUBA stent
Active Comparator: Self expandable stent; same to Balloon expandable stent	Device: 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; Other Names: COMPLETE SE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	Limb salvage (free of above-the-ankle amputation)	1 year
Clinical outcome	Sustained clinical improvement rate at 12 month follow-up	1 year
Clinical outcome	Ankle-brachial index (ABI) at 12 months	1 year
Clinical outcome	The rate of major adverse cardiovascular events (MACE) at 12 months	1 year
Clinical outcome	Repeated target lesion revascularization (TLR) rate	1year
Angiographic outcome	Stent fracture rate	1 year
Angiographic outcome	Incidence of geographic miss	1 year
Clinical outcome	Repeated target extremity revascularization (TER) rate	1 year

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Seung Woon Rha, MD. PhD, Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea

Publications and helpful links

General Publications

• Choi WG, Rha SW, Choi CU, Kim EJ, Oh DJ, Cho YH, Park SH, Lee SJ, Hur AY, Ko YG, Park SM, Kim KC, Kim JH, Kim MW, Kim SM, Bae JH, Bong JM, Kang WY, Seo JB, Jung WY, Cho JH, Kim do H, Ahn JH, Kim SH, Jang JY; SENS-ILIAC Investigators. Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial. Trials. 2016 Jun 25;17(1):302. doi: 10.1186/s13063-016-1435-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2012
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: atherosclerosis; stent; Peripheral artery disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Atherosclerosis
• Other Study ID Numbers: SENS-ILIAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No