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

March 13, 2018 updated by: Seung Woon Rha, Korea University Guro Hospital

Efficacy of Self-Expanding Nitinol S.M.A.R.T-CONTROL Stent Versus Complete SE Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease : Prospective, Multicenter, Randomized, Controlled Trial (SENS-FP Trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Five randomized, controlled trials failed to demonstrate any benefit of a stainless-steel stent over angioplasty alone. The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions. Several studies reported stent fractures were associated with a higher risk of in-stent restenosis and reocclusion. In vitro, Stefan et al. reported the 7 different SFA stents showed differences in the incidence of high strain zones, which indicates a potential for stent fracture, as demonstrated by the mechanical fatigue tests. They claimed differences in stent design might play a major role in the appearance of stent strut fracture related to restenosis and reocclusion. Also, in retrospective study, Iida et al. reported there was significant difference in stent fracture between S.M.A.R.T. stent group and Luminexx stent group and primary patency was worse in those associated with stent fracture than in those without stent fractures. Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment.

The design of self-expandible nitinol stents might be different depending on the developed time; The first-generation nitinol stents (e.g., LuminexxTM and SmartTM) showed a remarkably high rate of stent strut fracture. A second generation of slotted tube nitinol stents has been developed. These stents had a better flexibility, by reducing the number of connections between cells or crowns, and by configurating spiral orientation of these interconnections. Several studies reported that these nitinol stents are more fracture-resistant and more flexible, some of them providing superior patency rate (e.g., LifeTM and EverflexTM). However, the one of the important limitations to their studies is that those was the non-randomized study of relative small sample size or was confined to in-vitro. Upto date, the multicenter, randomized controlled trial for direct comparison of stent fracture and primary patency between two different nitinol stents has not been done except one study; SMART versus Luminexx stent. SMART and Luminexx stent have been classified into 1st generation self-expandable nitinol stent. Complete-SE stent of Medtronic company was different to Smart stent of Cordis company in that the configuration of interconnection of Complete-SE stent had peak-to-peak connection and more spiral orientation of interconnection, compared to mart stent. On the other hand, 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, to date, in previous many reports, the dual antiplatelet therapy consisted of aspirin and clopidogrel have proven to decrease the incidence of cardiovascular death, myocardial infarction, or revascularization without an increase in major bleeding in patients who underwent percutaneous coronary intervention regardless of stent type (bare metal stent or drug-eluting stent). In 2011 ESC (European society of cardiology) guideline, dual antiplatelet therapy with aspirin and a thienopyridine for at least one month is recommended after infra-inguinal bare metal stent implantation (Class I, Level C). However, there have been no the definite evidence or guideline for the optimal antiplatelet agents after stent implantation one month later. There have been many studies for the efficacy of thienopyridine in peripheral arterial disease. Also, With the potential benefit of cilostazol on vascular function in vitro, there have several previous efforts to prove the efficacy of cilostazol in patients undergoing endovascular therapy or stent implantation in peripheral arterial disease. However, still specific data regarding a variety of antiplatelet regimen are limited. Also, very few trials have effectively nor properly addressed the direct comparison for the efficacy and safety between clopidogrel and cilostazol. This trial designed to evaluate the efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 152-703
        • Cardiovascular Center, Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical criteria

    1. Age 20 years of older
    2. 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)
    3. Patients with signed informed consent

  • Anatomical criteria

    1. Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral femoropopliteal artery
    2. Patent (≤50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (≤30% residual stenosis),
    3. At least one patent (less than 50% stenosed) tibioperoneal run-off 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 medication: heparin, aspirin, clopidogrel, cilostazol, or contrast agent
  4. Acute limb ischemia
  5. Previous bypass surgery or stenting of the ipsilateral femoropopliteal artery
  6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
  7. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required
  8. Patients with life expectancy <1 year due to comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Complete SE Stent
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
same to SMART CONTROL Stent
ACTIVE_COMPARATOR: SMART CONTROL Stent
same to Complete SE
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of binary restenosis
Time Frame: one year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index
Time Frame: 1 year
  1. stent fracture rate according to fracture grade (minor, moderate, severe
  2. Limb salvage rate free of above-the-ankle amputation
  3. Sustained clinical improvement rate at 12 month follow-up
  4. Repeated target lesion revascularization (TLR) rate
  5. Repeated target extremity revascularization (TER) rate
  6. Total re-occlusion rate
  7. Comparison of angiographic variables consisted of late loss and % restenosis
  8. Ankle-brachial index (ABI) at 12 months
  9. The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction, and stroke at 12 months
  10. Incidence of geographic miss during stent deployment due to jumping and elongation
  11. The rate of binary restenosis or PSVR ≥ 2.5 or zero according to clopidogrel and cilostazol
  12. Major bleeding rate between clopidogrel and cilostazol group.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Guro Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SENS-FP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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