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

NCT01570803 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-15

No results posted yet for this study

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

Interventions

DEVICE

S.M.A.R.T CONTROL Stent

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.

DEVICE

Complete SE Stent

same to SMART CONTROL Stent

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Seung-Woon Rha, MD, PhD · Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570803 on ClinicalTrials.gov