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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by be Medical
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01816854
First received: March 20, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Atherosclerotic Heart Disease
Device: Stenting

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent

Further study details as provided by be Medical:

Primary Outcome Measures:
  • Binary restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Binary restenosis is defined as a re-obstruction ≥ 50% of the target lesion (peak systolic velocity ratio > 2.4).


Secondary Outcome Measures:
  • Immediate procedural outcome (procedural, technical and device success) [ Time Frame: peri-procedural ] [ Designated as safety issue: Yes ]

    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.


  • Distribution of Rutherford stages [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Primary sustained clinical improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Secondary sustained clinical improvement at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Defined as sustained upward shift of at least one category on the Rutherford classification including the need for repeated TLR in surviving patients.

  • Mortality [ Time Frame: 30-day mortality ] [ Designated as safety issue: Yes ]
    post-procedural

  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Repeated target lesion revascularization (TLR) rate [ Time Frame: 12 months ]
  • Repeated target extremity revascularization (TER) rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Amputation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of patient clopidogrel resistance [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with PAD Device: Stenting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01816854

Contacts
Contact: Jeroen Hendriks, MD, PhD +32 3 821 30 00 jeroen.hendriks@uza.be
Contact: Joris Coteur, MSc

Locations
Belgium
Antwerp University Hospital Recruiting
Antwerp, Belgium, 2650
Contact: Jeroen Hendriks, MD, PhD         
Sponsors and Collaborators
be Medical
Investigators
Principal Investigator: Jeroen Hendriks, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: be Medical
ClinicalTrials.gov Identifier: NCT01816854     History of Changes
Other Study ID Numbers: BM-HERO-07
Study First Received: March 20, 2013
Last Updated: May 13, 2014
Health Authority: Belgium: FAMHP

Keywords provided by be Medical:
SFA,
stent,
endovascular
Patient outcome

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014