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Drug Eluting Stents In The Critically Ischemic Lower Leg 2 (DESTINY 2)

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ClinicalTrials.gov Identifier: NCT01442636
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : March 9, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: stent Phase 2 Phase 3

Detailed Description:

The aim of this research is to evaluate the immediate and long term outcome of the XIENCE PRIME EverolimusEluting Coronary Stent System in a prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries.

The research question is "Dose the use of an Everolimus coated stent in long tibial artery occlusions, between 3 and 10cm offer superior patency at 12 months compared to a historical cohort of bare metal stents in similar lesions?" Our hypothesis is that the use of everolimus coated stents in tibial artery occlusions between 3 and 10cm will result in lower binary restenosis than was historically found in equivalent but non-drugcoated bare metal stents.

Currently, there is evidence that angioplasty and drug eluting stents can be used as a therapy for patients with critical limb ischemia due to occlusive infrapopliteal disease. The XIENCE PRIME™ Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS or XIENCE PRIME stent system) is manufactured by Abbott. It is a device/drug combination product consisting of the CobaltChromium MULTILINK VISION 8 Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a nonerodible polymer. The XIENCE PRIME Everolimus Eluting Coronary Stent is coated with everolimus (active ingredient), embedded in a nonerodible polymer (inactive ingredient). Everolimus is the active pharmaceutical ingredient in the XIENCE PRIME stent. It is a novel semisynthetic macrolide immunosuppressant, synthesized by chemical modification of rapamycin (sirolimus). The everolimus chemical name is 40O(2hydroxyethyl) rapamycin.

The XIENCE PRIME stent contains inactive ingredients including poly n-butyl methacrylate (PBMA), a polymer that adheres to the stent and drug coating, and PVDFHFP, which is comprised of vinylidene fluoride and hexafluoropropylene monomers as the drug matrix layer containing everolimus. PBMA is a homopolymer with a molecular weight (Mw) of 264,000 to 376,000 dalton. PVDFHFP is a nonerodible semicrystalline random copolymer with a molecular weight (Mw) of 254,000 to 293,000 dalton. The drug matrix copolymer is mixed with everolimus (83%/17% w/w polymer/everolimus ratio) and applied to the entire PBMA coated stent surface. The drug load is 100 μg/cm2 for all product sizes. No top-coat layer is used.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg
Study Start Date : July 2011
Primary Completion Date : November 2013
Study Completion Date : November 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Xience Prime stent
Patients with critical limb ischemia due to below the knee arterial lesion between 30 and 100mm in length, treated with the XIENCE PRIME™ Everolimus Eluting Coronary Stent System.
Device: stent
Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
Other Name: Xience Prime stent

Outcome Measures

Primary Outcome Measures :
  1. Primary patency at 12 months [ Time Frame: 12 months ]
    Absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography

Secondary Outcome Measures :
  1. Technical success [ Time Frame: procedure ]
    The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%

  2. Hemodynamic primary patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ]
    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.

  3. Limb-salvage rate at all follow-up visits [ Time Frame: 1, 6, 12-month follow-up ]
    Absence of major amputation. Major amputation is 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).

  4. Primary assisted patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ]
    Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.

  5. Secondary patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ]
    Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.

  6. Target lesion revascularization (TLR) at all follow-up visits [ Time Frame: 1, 6, 12-month follow-up ]
    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.

  7. Clinical success at all follow-up visits [ Time Frame: 1, 6, 12-month ]
    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.

  8. Serious adverse events until follow-up completions [ Time Frame: 1,6,12 months and interim visits ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Patient is eligible for treatment with the XIENCE PRIME stent (Abbott Vascular)
  • 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:

  • De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
  • Total target lesion length minimally 30mm and maximally 100mm
  • Target vessel diameter visually estimated to be >2.0mm and <3.5mm
  • Guidewire and delivery system successfully traversed lesion

Exclusion Criteria:

  • Patient refusing treatment
  • 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
  • Non-atherosclerotic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442636

Australia, New South Wales
Prince of Wales Private Hospital
Randwick, New South Wales, Australia, 2031
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
Department Vascular Surgery, A.Z. Sint-Blasius Hospital
Dendermonde, East-Flanders, Belgium, 9200
Herz-zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Leipzig, Germany, 04289
St Fransiskus hospital
Münster, Germany, 48145
Sponsors and Collaborators
Flanders Medical Research Program
Principal Investigator: Marc Bosiers, MD A.Z. Sint-Blasius Hospital
More Information

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01442636     History of Changes
Other Study ID Numbers: FMRP-101021
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases