Clinical trial NCT01834495: Efficacy of Balloon-Expandable Stent Versus Self-Expandable Stent for the Atherosclerotic ILIAC Arterial Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Atherosclerosis
Keywords: Peripheral artery disease
atherosclerosis
stent
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Primary patency rate
timeFrame: 1year
Secondary outcomes:
measure: Clinical outcome
timeFrame: 1 year
measure: Clinical outcome
timeFrame: 1 year
measure: Clinical outcome
timeFrame: 1 year
measure: Clinical outcome
timeFrame: 1 year
measure: Clinical outcome
timeFrame: 1year
measure: Angiographic outcome
timeFrame: 1 year
measure: Angiographic outcome
timeFrame: 1 year
measure: Clinical outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Cardiovascular center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
name: Seung Woon Rha, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.