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

NCT01834495 | Completed DMC

• 1 other identifier: SENS-ILIAC
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease; Atherosclerosis

Keywords

Peripheral artery disease; atherosclerosis; stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical outcome

  1 year

• Clinical outcome

  1 year

• Clinical outcome

  1 year

• Clinical outcome

  1 year

• Clinical outcome

  1year

Study Arms (2)

Balloon expandable stent

EXPERIMENTAL

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

Self expandable stent

ACTIVE COMPARATOR

same to Balloon expandable stent

Device: Self expandable stent

Interventions

Balloon expandable stent DEVICE

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

Also known as: SCUBA stent

Balloon expandable stent

Self expandable stent DEVICE

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

Also known as: COMPLETE SE

Self expandable stent

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical criteria:
• 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)
• Patients with signed informed consent
• \. Anatomical criteria:
• Target lesion length ≥ 4 cm by angiographic estimation,
• Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,
• Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis),
• At least one patent (less than 50% stenosed) tibioperoneal runoff vessel.

You may not qualify if:

• Disagree with written informed consent
• Major bleeding history within prior 2 months
• Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agent
• Acute limb ischemia
• Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion)
• Patients that major amputation ("above the ankle" amputation) has been done, is planned or required
• Patients with life expectancy \<1 year due to comorbidity
• Age \> 85 years

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Related Publications (2)

• Choi WG, Rha SW, Choi BG, Park S, Kim JB, Kang DO, Choi CU, Seo YS, Cho YH, Park SH, Lee SJ, Ko YG, Her AY, Kim SM, Kim KC, Cho JH, Kang WY, Kim JH, Kim MW, Kim DH, Bae JH, Ahn JH, Jo SC, Seo JB, Jung WY, Park SM; SENS-ILIAC Investigators. Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial. Heart Vessels. 2024 Dec;39(12):1060-1067. doi: 10.1007/s00380-024-02431-4. Epub 2024 Jul 2.

  PMID: 38953938 DERIVED

• 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.

  PMID: 27344435 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Seung Woon Rha, MD. PhD

  Cardiovascular center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: April 18, 2013
• Study Start: October 28, 2012
• Primary Completion: January 31, 2018
• Study Completion: February 11, 2019
• Last Updated: August 14, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)