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

NCT ID: NCT01653600

Last Updated: 2012-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-08-31

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.

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)

Conditions

Peripheral Arterial Disease; Atherosclerosis

Keywords

peripheral arterial disease; atherosclerosis; nitinol; stents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LifeStent

same to SMART CONTROL Stent

Group Type: EXPERIMENTAL

LifeStent

Intervention Type: DEVICE

same to SMART STENT

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

Group Type: ACTIVE_COMPARATOR

S.M.A.R.T CONTROL Stent

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

LifeStent

same to SMART STENT

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung Woon Rha

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung-Woon Rha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Seung-Woon Rha, MD, PhD

Role: CONTACT

Phone: 82-2-818-6387

Email: swrha617@yahoo.co.kr

Sang-Ho Park, MD

Role: CONTACT

Phone: 82-41-570-3670

Email: matsalong@schmc.ac.kr

Facility Contacts

Seung Woon Rha, MD, PhD

Role: primary

Sang Ho Park, MD

Role: backup

Other Identifiers

SENS-FP-2-LifeStent Arm

Identifier Type: -

Identifier Source: org_study_id