Efficacy of Self-Expanding Nitinol S.M.A.R.T CONTROL Stent Versus Life Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease (SENS-FP-2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Korea University Guro Hospital
Sponsor:
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT01653600
First received: April 9, 2012
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Atherosclerosis
Device: S.M.A.R.T CONTROL Stent
Device: LifeStent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Self-Expanding Nitinol S.M.A.R.T CONTROLTM Stent Versus Life Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease : Prospective, Multicenter, Randomized, Controlled Trial (SENS-FP-2 Trial)

Resource links provided by NLM:


Further study details as provided by Korea University Guro Hospital:

Primary Outcome Measures:
  • The rate of binary restenosis [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    1. Stent fracture rate
    2. Limb salvage free of above-the-ankle amputation
    3. Sustained clinical improvement rate
    4. Repeated target lesion revascularization rate
    5. Repeated target extremity revascularization rate
    6. Total re-occlusion rate
    7. Anigoraphic variables (Late loss, % restenosis)
    8. Ankle-brachial index
    9. The rate of major adverse cardiovascular events (MACE)
    10. The incidence of the stent geographic miss during stent deployment
    11. binary restenosis rate according to cilostazol use duration upto 12 month and 6 month


Estimated Enrollment: 346
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LifeStent
same to SMART CONTROL Stent
Device: LifeStent
same to SMART STENT
Active Comparator: SMART CONTROL 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 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
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.

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 lesions. Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. In vitro, Stefan et al. reported difference in stent design might play a major role in the appearance of stent strut fracture related to restenosis and reocclusion. Also, several retrospective or registry clinical studies reported stent fractures were associated with a higher risk of in-stent restenosis and reocclusion. 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 (lesion length between 5-22 cm). Furthermore, in the Asian population, the study of this type have never been performed. 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, 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 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 (6 month versus 12 month)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Target lesion length < 3 cm by angiographic estimation
    2. Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral femoropopliteal artery
    3. Patent (≤50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (≤30% residual stenosis),
    4. 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 hypersensitivy or contraindication to any of the following medication: heparin, aspirin, clopidogrel 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
  9. end-staged renal failure on hemodialysis or peritoneal dialysis
  10. Age > 85 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653600

Contacts
Contact: Seung-Woon Rha, MD, PhD 82-2-818-6387 swrha617@yahoo.co.kr
Contact: Sang-Ho Park, MD 82-41-570-3670 matsalong@schmc.ac.kr

Locations
Korea, Republic of
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Seung Woon Rha, MD, PhD    82-2-818-6387    swrha617@yahoo.co.kr   
Contact: Sang Ho Park, MD    82-41-570-3670    matsalong@schmc.ac.kr   
Principal Investigator: Seung Woon Rha, MD, PhD         
Sub-Investigator: Sang Ho Park, MD         
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
Principal Investigator: Seung-Woon Rha, MD, PhD Cardiovascular Center, Korea University Guro Hospital, 80, Guro-dong, Guro-gu, Seoul, 152-703, Korea
  More Information

No publications provided

Responsible Party: Seung Woon Rha, Associate professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT01653600     History of Changes
Other Study ID Numbers: SENS-FP-2-LifeStent Arm
Study First Received: April 9, 2012
Last Updated: July 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University Guro Hospital:
peripheral arterial disease
atherosclerosis
nitinol
stents

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014