Efficacy Between Different Two Self-Expanding Nitinol Stents For The Atherosclerotic Femoro-Popliteal Arterial Disease

NCT01570803 | Withdrawn DMC

• 1 other identifier: SENS-FP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. Although there have been several retrospective or registry studies for atherosclerotic femoropopliteal disease in the East, there have been few randomized control trial for comparison of stent fracture and primary patency between different nitinol stents. Smart stent has the peak-to-valley bridge and in-line interconnection. Medtronics company have claimed Complete's stent crowns have been configured to minimize crown to crown interaction, increasing the stent's flexibility without compromising radial strength. We made the hypothesis that the design of Complete-SE stent might be more fracture-resistant or effective for in-stent restenosis, compared with Smart stent. On the other hand, 2011 ESC guideline recommended that dual antiplatelet therapy with aspirin and a thienopyridine for at least one month is recommended after infrainguinal bare-metal-stent implantation. Recent meta-analysis has shown that the efficacy of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However, still specific data regarding a variety of antiplatelet regimen are limited. To date, there is no the study for comparison between clopidogrel and cilostazole in patient undergone stent implantation in femoropopliteal lesion. In conclusion, 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 Complete SE) and to compare binary restenosis rate between clopidogrel and cilostazol in femoropopliteal arterial lesion.

Conditions

Arterial Disease; Atherosclerosis

Keywords

peripheral arterial disease,; atherosclerosis,; nitinol,; stents

Outcome Measures

Primary Outcomes (1)

• The rate of binary restenosis

  the rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) or PSVR ≥ 2.5 or zero (PSVR=peak systolic velocity within the area of stenosis divided by peak systolic velocity in a normal adjacent proximal artery segment) in the treated segment at 12 months after intervention as determined by catheter angiography or Duplex ultrasound

  one year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

Complete SE Stent

EXPERIMENTAL

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 Complete-SE) stents. And then, patients received aspirin and clopidogrel during one month. After one month from index procedure, patients were randomized to receive either clopidogrel group (clopidogrel will not be changed but continue) or cilostazol group (clopidogrel will be changed into cilostazol) in separate groups of SMART group and Complete SE group. Randomization procedure will be performed using a web-based program

Device: Complete SE Stent

SMART CONTROL Stent

ACTIVE COMPARATOR

same to Complete SE

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

Complete SE Stent DEVICE

same to SMART CONTROL Stent

Complete SE Stent

Eligibility Criteria

• Age: 20 Years - 90 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
• 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 hypersensitivity or contraindication to any of the following medication: heparin, aspirin, clopidogrel, cilostazol, 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (2)

Cardiovascular center, Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Related Publications (1)

• Park SH, Rha SW, Choi CU, Kim EJ, Oh DJ, Cho YH, Choi WG, Lee SJ, Kim YH, Choi SH, Kim WH, Kim KC, Cho JH, Kim JH, Kim SM, Bae JH, Bong JM, Kang WY, Baek JY, Seo JB, Chung WY, Park MW, Her SH, Suh J, Kim MW, Kim YJ, Choi HJ, Soh JW; SENS-FP Investigators. Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial): study protocol for a randomized controlled trial. Trials. 2014 Sep 10;15:355. doi: 10.1186/1745-6215-15-355.

  PMID: 25208688 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease

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

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: Clinical Professor

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)