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

NCT01816854 | Completed

• 1 other identifier: BM-HERO-07-001
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerotic Heart Disease

Keywords

Peripheral artery disease; SFA; PPA; Self-expandable nitinol stent; Endovascular; Stenosis; Primary pantency

Outcome Measures

Primary Outcomes (1)

• Binary restenosis

  Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio \> 2.4).

  12 months

Secondary Outcomes (10)

• Immediate procedural outcome (procedural, technical and device success)

  peri-procedural

• Distribution of Rutherford stages

  12 months

• Primary sustained clinical improvement

  12 months

• Secondary sustained clinical improvement at 12 months

  12 months

• Mortality

  30-day mortality

Study Arms (1)

Patients with PAD

Device: Stenting

Interventions

Stenting DEVICE

Patients with PAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who suffer from intermittent claudication and critical limb ischemia (TASC A, B and C lesions).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• be Medical: lead

Study Sites (1)

Antwerp University Hospital

Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease; Peripheral Arterial Disease; Constriction, Pathologic

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Jeroen Hendriks, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: October 8, 2012
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

BE (1)