Peripheral Arterial DiseasePhase 2/3DESTINY 2NCT01442636
Drug Eluting Stents In The Critically Ischemic Lower Leg 2
A Phase 2/3 study testing stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2011to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Herz-zentrum Bad Krozingen
Bad Krozingen, 79189
Herzzentrum
Leipzig, 04289
St Fransiskus hospital
Münster, 48145
Belgium2 sites
Imelda Hospital
Bonheiden, Antwerp, 2820
Department Vascular Surgery, A.Z. Sint-Blasius Hospital
Dendermonde, East-Flanders, 9200
Australia1 site
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentDevice
Also called Xience Prime stent
Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
| Study group | Role | What they receive |
|---|---|---|
| Xience Prime stent | Experimental | 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. Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 12 months
Absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography
Measured: 12 months
Secondary outcomes (8)
Technical success
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Measured: procedure
Hemodynamic primary patency rate at 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.
Measured: 1, 6, 12-month follow-up
Limb-salvage rate at all follow-up visits
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).
Measured: 1, 6, 12-month follow-up
Primary assisted patency rate at 1, 6, 12-month follow-up
Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Measured: 1, 6, 12-month follow-up
Secondary patency rate at 1, 6, 12-month follow-up
Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
Measured: 1, 6, 12-month follow-up
Target lesion revascularization (TLR) at all follow-up visits
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.
Measured: 1, 6, 12-month follow-up
Clinical success at all follow-up visits
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.
Measured: 1, 6, 12-month
Serious adverse events until follow-up completions
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.
Measured: 1,6,12 months and interim visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, MD, Principal investigator, A.Z. Sint-Blasius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442636
- Sponsor's protocol ID
- FMRP-101021
- Acronym
- DESTINY 2
- Status last verified
- Mar 2015
- First submitted
- 22 Sep 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01442636
- Acronym / sponsor ID
- DESTINY 2 / FMRP-101021
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xience Prime stent | Experimental | Device: stentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stentAlso: Xience Prime stentImplantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems. | Device | Xience Prime stent |
Primary outcome
Primary patency at 12 months
Time frame: 12 months
Absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography
8 secondary outcomes
Technical success
Time frame: procedure
Hemodynamic primary patency rate at 1, 6, 12-month follow-up
Time frame: 1, 6, 12-month follow-up
Limb-salvage rate at all follow-up visits
Time frame: 1, 6, 12-month follow-up
Primary assisted patency rate at 1, 6, 12-month follow-up
Time frame: 1, 6, 12-month follow-up
Secondary patency rate at 1, 6, 12-month follow-up
Time frame: 1, 6, 12-month follow-up
Target lesion revascularization (TLR) at all follow-up visits
Time frame: 1, 6, 12-month follow-up
Clinical success at all follow-up visits
Time frame: 1, 6, 12-month
Serious adverse events until follow-up completions
Time frame: 1,6,12 months and interim visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bosiers, MD principal investigator
A.Z. Sint-Blasius Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.