PREVENT: Promus BTK

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Flanders Medical Research Program
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01500070
First received: December 19, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated.

In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.


Condition Intervention Phase
Peripheral Arterial Disease
Device: Everolimus-Eluting Stent (PROMUS ELEMENT)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK

Resource links provided by NLM:


Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • Primary patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.


Secondary Outcome Measures:
  • Technical success [ Time Frame: 1 day post-procedure ] [ Designated as safety issue: No ]
    The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

  • Hemodynamic primary patency rate [ Time Frame: 1, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow‐up.

  • Limb-salvage [ Time Frame: 1, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Absence of major amputation, defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot).

  • Primary assisted patency rate [ Time Frame: 1, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.

  • Secondary patency rate [ Time Frame: 1, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.

  • Target lesion revascularization (TLR) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as a repeat intervention to maintain or re‐establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.

  • Clinical success at follow-up [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as an improvement of Rutherford classification at 1 day and 1, 6, 12‐month follow‐up of one class or more as compared to the pre‐procedure Rutherford classification.

  • Improvement of ankle-brachial index (ABI) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as an increase of the ABI at 1 day and 1, 6, 12‐month follow‐up compared to baseline in subjects with compressible arteries and baseline ABI <0.9.

  • Serious Adverse Events (SAE) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ] [ Designated as safety issue: No ]
    Defined as any clinical event that is fatal, life‐threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.


Estimated Enrollment: 70
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug-eluting stent
Patients implanted with the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
Device: Everolimus-Eluting Stent (PROMUS ELEMENT)
PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
  • Patient is willing to comply with specified follow‐up evaluations at the specified times
  • Patient is >18 years old
  • Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient has a projected life‐expectancy of at least 12 months
  • The treating physician consider the patient eligible for below‐the‐knee treatment with the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston Scientific)
  • Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria:

  • Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk
  • A maximum of two focal target lesions in one or more infrapopliteal vessels
  • Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted
  • Target vessel diameter visually estimated to be >2.5mm and <4.0mm
  • Guidewire and delivery system successfully traversed lesion

General Exclusion Criteria:

  • Patient refusing treatment
  • Previously implanted stent in the artery to be treated
  • Failed PTA of target lesion/vessel less than 3 months prior to study procedure
  • The reference segment diameter is not suitable for the available stent design
  • Untreated flow‐limiting inflow lesions
  • Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
  • Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
  • Aneurysm in the target vessel
  • Patient presents with renal failure, evidenced by a serum creatinine level >2.0mg/dL
  • Patient presents with platelet levels above or below normal range
  • Non‐atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1‐year life expectancy
  • Major distal amputation (above the transmetatarsal) in the study limb or non‐study limb
  • Septicemia or bacteremia
  • Any previously known coagulation disorder, including hypercoagulability
  • Contraindication to anticoagulation or antiplatelet therapy
  • Known allergies to stent or stent components
  • Known allergy to contrast media that cannot be adequately pre‐medicated prior to the study procedure
  • Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin‐induced thrombocytopenia (HIT) type II
  • Currently participating in another clinical research trial
  • Angiographic evidence of intra‐arterial thrombus or atheroembolism from inflow treatment
  • Target lesion access not performed by transfemoral approach.
  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: NCT01500070

Contacts
Contact: Tineke Bonnarens +32 52 25 28 22 office@fmrp.be
Contact: Bavo Van Puyvelde, MHSc, MHA +32 52 25 28 22 bavo.vanpuyvelde@fmrp.be

Locations
Belgium
Imelda Hospital Recruiting
Bonheiden, Antwerpen, Belgium, 2820
Contact: Patrick Peeters, MD    +32 15 50 61 97    patrick.peeters@imelda.be   
Principal Investigator: Patrick Peeters, MD         
Sub-Investigator: Jurgen Verbist, MD         
OLV Aalst Recruiting
Aalst, Oost-Vlaanderen, Belgium, 9300
Contact: Lieven Maene, MD    +32 53 72 46 99    lmaene@hotail.com   
Principal Investigator: Lieven Maene, MD         
Sub-Investigator: Roel Beelen, MD         
AZ Sint-Blasius Recruiting
Dendermonde, Oost-Vlaanderen, Belgium, 9200
Contact: Marc Bosiers, MD    +32 32 52 25 27 35    marc.bosiers@telenet.be   
Sub-Investigator: Koen Deloose, MD         
Principal Investigator: Marc Bosiers, MD         
Sub-Investigator: Joren Callaert, MD         
RZ Heilig Hart Tienen Recruiting
Tienen, Belgium, 3300
Contact: Koen Keirse, MD    +32 (0) 16 80 99 72    keirsekoen@hotmail.com   
Contact: Lies Vanermen    +32 (0) 16 80 99 72    vaatheelkunde@rztienen.be   
Principal Investigator: Koen Keirse, MD         
Germany
Herzzentrum Leipzig Not yet recruiting
Leipzig, Freistaat Sachsen, Germany, 04289
Contact: Dierk Scheinert, MD    +49 3418 6517 40    dierk.scheinert@gmx.de   
Principal Investigator: Dierk Scheinert, MD         
Herzzentrum Bad-Krözingen Not yet recruiting
Bad-Krözingen, Land Baden-Württemberg, Germany, 79189
Contact: Thomas Zeller, MD    +497633402807    thomas.zeller@herzzentrum.de   
Principal Investigator: Thomas Zeller, MD         
St. Fransiskus Hospital Not yet recruiting
Münster, Nordrhein-Westfalen, Germany, 48145
Contact: Giovanni Torsello, MD    +49 (251) 9353933    giovanni.torsello@sfh.muenster.de   
Principal Investigator: Giovanni Torsello, MD         
New Zealand
Auckland City Hospital Not yet recruiting
Auckland City, Auckland, New Zealand, 1023
Contact: Andrew Holden, MD    +64 09 3797 440    andrewh@adhb.govt.nz   
Principal Investigator: Andrew Holden, MD         
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
Principal Investigator: Marc Bosiers, MD AZ Sint Blasius, Dendermonde, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01500070     History of Changes
Other Study ID Numbers: FMRP-101020
Study First Received: December 19, 2011
Last Updated: September 30, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Institutional Review Board
New Zealand: Medsafe

Keywords provided by Flanders Medical Research Program:
Peripheral Arterial Disease
Claudication
Drug-Eluting Stent
BTK
Everolimus
CLI

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014