Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

Atherosclerotic Heart Disease Clinical Trial

Official title:

Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816854
• Other study ID #: BM-HERO-07-001
• Status: Completed
• Start date: October 8, 2012
• Est. completion date: March 29, 2017

Study information

• Verified date: December 2018
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must sign informed consent prior to the index-procedure

• Patient must be older than 18 years

• Patient must be compliant with follow-up dates at 1 month and 12 months

• Patients with intermittent claudication (Rutherford 2-3) and critical limb ischemia (Rutherford 4-5)

• Target lesion is located in the superficial femoral artery (minimal 1 cm from origin of SFA and minimal 1 cm above the edge of the patella)

• Reference vessel diameter =4.5 and =6.5 mm (visual estimate)

• Patients with a TASC A, B or C lesion

• Diameter stenosis of target lesion >50% or chronic occlusions

• Inflow arteries are free of hemodynamically significant obstruction (i.e. =50%)

• The popliteal artery (outflow) is free of hemodynamically significant obstruction (i.e. =50%)

• At least 1 patent below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle confirmed by baseline angiography

Exclusion Criteria:

• Patients with Rutherford 1 and 6

• Patiens with Serum creatinine > 2.0 mg/dL or renal dialysis

• Patient takes esomeprazole or omeprazole

• Patient is pregnant

• Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability

• Target lesion cannot be crossed with a guidewire

• Target lesion is located in the popliteal artery

• Patients with a nickel-titanium allergy

• Patients with an aneurysm in the superficial femoral artery and popliteal artery

• Patients with a TASC D lesion

• Patients with a life expectancy <1 year

• Patients with scheduled elective non-vascular procedures within 3 months after index-procedure, vascular procedures are allowed within 3 months after index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted

• Patients with previous bypass surgery in the SFA

• Patients with intolerance to antithrombotic medication (acetylic salicylic acid, clopidogrel, ticlopidine, glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, etc)

• Patient has not been premedicated with acetylic salicylic acid (at least 80 mg/day) 2 hours before the index-procedure

• Patient has not been premedicated with clopidogrel (600 mg/day) 2 hours before the index-procedure

Related Conditions & MeSH terms

• Atherosclerotic Heart Disease
• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Stenting

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
be Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary restenosis	Binary restenosis is defined as a re-obstruction = 50% of the target lesion (peak systolic velocity ratio > 2.4).	12 months
Secondary	Immediate procedural outcome (procedural, technical and device success)	Procedural success: combination of technical success, device success and absence of procedural complications.; Technical success: successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography.; Device success: exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and in case of digital substraction angiography, in at least two different imaging projections.	peri-procedural
Secondary	Distribution of Rutherford stages		12 months
Secondary	Primary sustained clinical improvement	Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.	12 months
Secondary	Secondary sustained clinical improvement at 12 months	Defined as sustained upward shift of at least one category on the Rutherford classification including the need for repeated TLR in surviving patients.	12 months
Secondary	Mortality	post-procedural	30-day mortality
Secondary	Mortality		12 months
Secondary	Repeated target lesion revascularization (TLR) rate		12 months
Secondary	Repeated target extremity revascularization (TER) rate		12 months
Secondary	Amputation rate		12 months
Secondary	Rate of patient clopidogrel resistance		1 month