Peripheral Vascular DiseasePhase 2DESTINYNCT00510393
Drug Eluting Stents In The Critically Ischemic Lower Leg
A Phase 2 study testing XIENCE V everolimus eluting coronary stent system and MULTILINK VISION coronary stent system in people with Peripheral Vascular Disease and Critical Limb Ischemia, run by Flanders Medical Research Program at 5 sites in 3 countries.
Trial summary
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Critical Limb Ischemia
- What is being tested?
- XIENCE V everolimus eluting coronary stent system and MULTILINK VISION coronary stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2008to Nov 2010
- Phase
- Phase 2
- 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
- Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
- A maximum of two focal target lesions in one or more infrapopliteal vessels
- Length of lesion is maximally 40 mm, allowing maximally 2 stents to be implanted
- Reference vessel diameter should be 2-3.5 mm
- Symptomatic critical limb ischemia (Rutherford 4, 5)
- The patient must be > 18 years of age
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- Life-expectancy of more than 12 months
- The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
- The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
- The patient must provide written patient informed consent that is approved by the ethics committee
Who cannot join
- Patient refusing treatment
- The reference segment diameter is not suitable for available stent design.
- Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis
- Untreatable lesion located at the distal outflow arteries
- More than two infrapopliteal lesions in the same limb
- Previously implanted stent(s) or PTA at the same lesion site
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- Lesion location requiring kissing stent procedure
- Lesion lies within or adjacent to an aneurysm
- Inflow-limiting arterial lesions left untreated
- The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
- The patient takes Phenprocoumon (Marcumar).
- The patient has a history of prior life-threatening contrast media reaction.
- The patient is currently enrolled in another investigational device or drug trial.
- The patient is currently breast-feeding, pregnant or intends to become pregnant.
- The patient is mentally ill or retarded.
- Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
- Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
- Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
- Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
- Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Belgium2 sites
Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, 9200
Germany2 sites
Herz-zentrum Bad Krozingen
Bad Krozingen, 79189
Herzzentrum
Leipzig, 04289
About this study
Official title: The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg
The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.
- Being tested
- XIENCE V everolimus eluting coronary stent system, MULTILINK VISION coronary stent system
- Keywords
- Critical Limb Ischemia, CLI, Drug Eluting Stent, DES, Bare Metal Stent, BMS
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE V everolimus eluting coronary stent systemDevice
MULTILINK VISION coronary stent systemDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | drug eluting stent Receives: Device: XIENCE V everolimus eluting coronary stent system |
| 2 | Placebo comparator | Bare Metal Stent Receives: Device: MULTILINK VISION coronary stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).
Measured: one year
Secondary outcomes (5)
Technical success defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.
Measured: procedure
Primary patency rate at each follow-up. Patients that did not receive any BTK-reintervention and do not exhibit significant restenosis on duplex (PVR ≥ 2.4) are defined as being primary patent at the given follow-up.
Measured: one year
Limb-salvage rate (LSR) defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot).
Measured: one year
Clinical events defined as 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: one year
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startMar 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Investigators
- Marc Bosiers, MD, Principal investigator, AZ Sint-Blasius, Dendermonde, BelgiumDierk Scheinert, MD, Principal investigator, Herzzentrum, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510393
- Sponsor's protocol ID
- FMRP-002
- Acronym
- DESTINY
- Status last verified
- Dec 2010
- First submitted
- 1 Aug 2007
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.
PubMed 22169682
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg
- ClinicalTrials.gov ID
- NCT00510393
- Acronym / sponsor ID
- DESTINY / FMRP-002
- Keywords
- Critical Limb Ischemia, CLI, Drug Eluting Stent, DES, Bare Metal Stent, BMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Mar 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Aug 2007 (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 Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: XIENCE V everolimus eluting coronary stent systemdrug eluting stent |
| 2 | Placebo comparator | Device: MULTILINK VISION coronary stent systemBare Metal Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
- A maximum of two focal target lesions in one or more infrapopliteal vessels
- Length of lesion is maximally 40 mm, allowing maximally 2 stents to be implanted
- Reference vessel diameter should be 2-3.5 mm
- Symptomatic critical limb ischemia (Rutherford 4, 5)
Key exclusion criteria (20 listed)
- Patient refusing treatment
- The reference segment diameter is not suitable for available stent design.
- Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis
- Untreatable lesion located at the distal outflow arteries
- More than two infrapopliteal lesions in the same limb
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 |
|---|---|---|
| XIENCE V everolimus eluting coronary stent system | Device | 1 |
| MULTILINK VISION coronary stent system | Device | 2 |
Primary outcome
Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).
Time frame: one year
5 secondary outcomes
Technical success defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.
Time frame: procedure
Primary patency rate at each follow-up. Patients that did not receive any BTK-reintervention and do not exhibit significant restenosis on duplex (PVR ≥ 2.4) are defined as being primary patent at the given follow-up.
Time frame: one year
Limb-salvage rate (LSR) defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot).
Time frame: one year
Clinical events defined as 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.
Time frame: one year
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: one year
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 2 Dec 2010.
- Derived from this study: PubMed 22169682Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.
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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
AZ Sint-Blasius, Dendermonde, Belgium
Dierk Scheinert, MD principal investigator
Herzzentrum, Leipzig, Germany
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XIENCE V everolimus eluting coronary stent system and MULTILINK VISION coronary stent system in people with Peripheral Vascular Disease and Critical Limb Ischemia, run by Flanders Medical Research Program at 5 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 10 inclusion and 20 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany, France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510393, which also lists 1 linked publication.
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 2 Dec 2010.