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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01442636




Registration number
NCT01442636
Ethics application status
Date submitted
22/09/2011
Date registered
28/09/2011
Date last updated
9/03/2015

Titles & IDs
Public title
Drug Eluting Stents In The Critically Ischemic Lower Leg 2
Scientific title
a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg
Secondary ID [1] 0 0
FMRP-101021
Universal Trial Number (UTN)
Trial acronym
DESTINY 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - stent

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.


Treatment: Devices: stent
Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary patency at 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
procedure
Secondary outcome [2] 0 0
Hemodynamic primary patency rate at 1, 6, 12-month follow-up
Timepoint [2] 0 0
1, 6, 12-month follow-up
Secondary outcome [3] 0 0
Limb-salvage rate at all follow-up visits
Timepoint [3] 0 0
1, 6, 12-month follow-up
Secondary outcome [4] 0 0
Primary assisted patency rate at 1, 6, 12-month follow-up
Timepoint [4] 0 0
1, 6, 12-month follow-up
Secondary outcome [5] 0 0
Secondary patency rate at 1, 6, 12-month follow-up
Timepoint [5] 0 0
1, 6, 12-month follow-up
Secondary outcome [6] 0 0
Target lesion revascularization (TLR) at all follow-up visits
Timepoint [6] 0 0
1, 6, 12-month follow-up
Secondary outcome [7] 0 0
Clinical success at all follow-up visits
Timepoint [7] 0 0
1, 6, 12-month
Secondary outcome [8] 0 0
Serious adverse events until follow-up completions
Timepoint [8] 0 0
1,6,12 months and interim visits

Eligibility
Key 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

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
East-Flanders
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Krozingen
Country [4] 0 0
Germany
State/province [4] 0 0
Leipzig
Country [5] 0 0
Germany
State/province [5] 0 0
Münster

Funding & Sponsors
Primary sponsor type
Other
Name
Flanders Medical Research Program
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Bosiers, MD
Address 0 0
A.Z. Sint-Blasius Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01442636