Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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/Phase 3
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01442636
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01442636