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

Atherosclerosis Clinical Trial

— SENS-FP-2  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01653600
• Other study ID #: SENS-FP-2-LifeStent Arm
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 9, 2012
• Last updated: July 27, 2012
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: July 2012
• Source: Korea University Guro Hospital
• Contact: Seung-Woon Rha, MD, PhD
• Phone: 82-2-818-6387
• Email: swrha617[@]yahoo.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 346
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.
• LifeStent
same to SMART STENT

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of binary restenosis	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.	one year	No
Secondary	stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index	Stent fracture rate; Limb salvage free of above-the-ankle amputation; Sustained clinical improvement rate; Repeated target lesion revascularization rate; Repeated target extremity revascularization rate; Total re-occlusion rate; Anigoraphic variables (Late loss, % restenosis); Ankle-brachial index; The rate of major adverse cardiovascular events (MACE); The incidence of the stent geographic miss during stent deployment; binary restenosis rate according to cilostazol use duration upto 12 month and 6 month	1 year	Yes