Efficacy of Self-Expanding Nitinol S.M.A.R.T CONTROL Stent Versus Life Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease

NCT01653600 | Unknown Phase 4 DMC

• 1 other identifier: SENS-FP-2-LifeStent Arm
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery lesions. Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. In the literature, however, prospective, randomized, controlled, clinical trial for comparison of stent fracture and primary patency between different nitinol stents has never been performed except one study; SMART versus Luminexx stent named SuperSL trial. LifeStent is similar to S.M.A.R.T. stent in the design consisted of the peak-to-valley connected with S-shaped bridge but is different in lesser bridge (4 bridge vs. 6 bridge), large cell size on stent ends, and larger cell size than S.M.A.R.T. On the other hand, Recent meta-analysis has shown that the efficaty of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However, still specific data regarding a variety of antiplatelet regimen in implanted femoropopliteal lesion are limited. Upto date, in the literature, never has never been performed the clinical trial for optimal duration of cilostazol use in the patient undergone stent implantation for femoropopliteal lesion. Thus, The purpose of our study is to examine and compare Primary patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL versus Lifestent) in femoropopliteal arterial lesion and to examine and compare the optimal duration of cilostazol use.

Conditions

Peripheral Arterial Disease; Atherosclerosis

Keywords

peripheral arterial disease; atherosclerosis; nitinol; stents

Outcome Measures

Primary Outcomes (1)

• The rate of binary restenosis

  binary restenosis is defined as the restenosis of at least 50 percent of the luminal diameter in the treated segment at 12 months after intervention, when determined by catheter angiography.

  one year

Secondary Outcomes (1)

• stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index

  1 year

Study Arms (2)

LifeStent

EXPERIMENTAL

same to SMART CONTROL Stent

Device: LifeStent

SMART CONTROL Stent

ACTIVE COMPARATOR

study design is 2x2 randomization design. First, before randomization, stratification will be performed according to lesion length 15cm criteria at web-based computerized program. Patients will be randomized in a 1:1 manner according to different two (SMART versus LifeStent) stents. And then, patients received aspirin and clopidogrel during one month. After one month from index procedure, clopidogrel will be stopped and changed into cilostazol. Patients were randomized to receive cilostazol 100mg bid either 11 month duration or 5 month duration in separate groups of SMART stent group and LifeStent group. Randomization procedure will be performed using a web-based program

Device: S.M.A.R.T CONTROL Stent

Interventions

S.M.A.R.T CONTROL Stent DEVICE

Provisional stenting should be performed; the case that optimal ballooning response is not obtained (sub-optimal balloon response) should be enrolled. The procedure is usually done, as follows; After the guidewire is passed through the target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Recommended, minimal balloon dilation time is 120 seconds. The sub-optimal balloon response is defined as a residual pressure gradient of \>15 mmHg, residual stenosis of \>30%, and flow-limiting dissection.

SMART CONTROL Stent

LifeStent DEVICE

same to SMART STENT

LifeStent

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
• Age 20 years of older
• Symptomatic peripheral-artery disease with (Rutherford 2 - 6); moderate to severe claudication (Rutherford 2-3), chronic critical limb ischemia with pain while was at rest (Rutherford 4), or with ischemic ulcers (Rutherford 5-6)
• Patients with signed informed consent
• Anatomical criteria
• Target lesion length \< 3 cm by angiographic estimation
• Stenosis of \>50% or occlusive atherosclerotic lesion of the ipsilateral femoropopliteal artery
• Patent (≤50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (≤30% residual stenosis),
• At least one patent (less than 50% stenosed) tibioperoneal run-off vessel.

You may not qualify if:

• Disagree with written informed consent
• Major bleeding history within prior 2 months
• Known hypersensitivy or contraindication to any of the following medication: heparin, aspirin, clopidogrel or contrast agent
• Acute limb ischemia
• Previous bypass surgery or stenting of the ipsilateral femoropopliteal artery
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% 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
• end-staged renal failure on hemodialysis or peritoneal dialysis
• Age \> 85 years

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Seung-Woon Rha, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Woon Rha, MD, PhD

CONTACT

82-2-818-6387; swrha617@yahoo.co.kr

Sang-Ho Park, MD

CONTACT

82-41-570-3670; matsalong@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: July 31, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

KR (1)