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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06410313




Registration number
NCT06410313
Ethics application status
Date submitted
1/05/2024
Date registered
13/05/2024
Date last updated
8/10/2024

Titles & IDs
Public title
First in Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients with Superficial Femoral Artery Disease And/or Proximal Popliteal Artery Disease
Scientific title
First in Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients with Superficial Femoral Artery Disease And/or Proximal Popliteal Artery Disease
Secondary ID [1] 0 0
ChampioNIR DES-001
Universal Trial Number (UTN)
Trial acronym
CHAMPIONSHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Femoral Artery Stenosis 0 0
Popliteal Artery Stenosis 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ChampioNIR Ridaforolimus Eluting Peripheral Stent System

Experimental: ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System - ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System


Treatment: Devices: ChampioNIR Ridaforolimus Eluting Peripheral Stent System
ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary patency of the target lesion
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Primary safety endpoint
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Primary patency
Timepoint [1] 0 0
30 days and 12 months
Secondary outcome [2] 0 0
Acute device success
Timepoint [2] 0 0
During the index procedure
Secondary outcome [3] 0 0
Acute procedural success
Timepoint [3] 0 0
During the index procedure
Secondary outcome [4] 0 0
Acute technical success
Timepoint [4] 0 0
During the index procedure
Secondary outcome [5] 0 0
Secondary Patency
Timepoint [5] 0 0
30 days 6, 12, 24 and 36 months
Secondary outcome [6] 0 0
Change of Rutherford classification
Timepoint [6] 0 0
30 days 6, 12, 24 and 36 months
Secondary outcome [7] 0 0
Change of resting ankle-brachial index (ABI)
Timepoint [7] 0 0
30 days 6, 12, 24 and 36 months
Secondary outcome [8] 0 0
Change in walking impairment questionnaire
Timepoint [8] 0 0
30 days 6, 12, 24 and 36 months
Secondary outcome [9] 0 0
Combined rate of the following events: death at 30 days, target vessel revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by =2 classes (as compared to post-procedural assessment)
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Stent fracture
Timepoint [10] 0 0
12 and 36 months
Secondary outcome [11] 0 0
Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
All-cause death
Timepoint [12] 0 0
30 days, 6, 12, 24 and 36 months
Secondary outcome [13] 0 0
Amputation (above the ankle)-Free Survival (AFS)
Timepoint [13] 0 0
30 days, 6, 12, 24 and 36 months
Secondary outcome [14] 0 0
Target Vessel Revascularization (TVR)
Timepoint [14] 0 0
30 days, 6, 12, 24 and 36 months
Secondary outcome [15] 0 0
Target Lesion Revascularization (TLR)
Timepoint [15] 0 0
30 days, 6, 12, 24 and 36 months
Secondary outcome [16] 0 0
Rate of Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
Timepoint [16] 0 0
30 days, 6, 12, 24 and 36 months
Secondary outcome [17] 0 0
Major Adverse Limb Events (MALE)
Timepoint [17] 0 0
30 days, 6, 12, 24 and 36 months

Eligibility
Key inclusion criteria
1. Age = 18 years and of age of legal consent.
2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
3. A single superficial femoral artery lesion with >50% stenosis or total occlusion.
4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) = 150 mm.
5. Reference vessel diameter (RVD) = 3.0 mm and = 5.0 mm by visual assessment.
6. Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
7. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
9. The subject is eligible for standard surgical repair, if necessary.
10. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
2. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
3. Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
4. Presence of residual =30% stenosis after either PTA or stenting of the inflow lesion.
5. Presence of an ipsilateral arterial artificial graft.
6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
7. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
8. Required stent placement (in the target or any other lesion) via a retrograde approach.
9. Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
10. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
11. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
12. Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
13. Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
14. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
15. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
16. Overlapping stents are not allowed.
17. Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
18. Stroke within the previous 30 days of the index procedure.
19. Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), PDLG, PLC, PDL, limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds) or contrast agent, that cannot be medically managed.
20. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
21. Known or suspected active systemic infection at the time of the procedure.
22. Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
23. Platelet count <50,000/µL
24. International normalized ratio (INR) > 1.5
25. GFR <30 ml/min by Cockroft-Gault.
26. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
27. Planned use of a drug coated balloon (DCB) during the index procedure.
28. Pregnant women or women of childbearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment.
29. Subject is participating in any investigational study that has not yet reached its primary endpoint

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medinol Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brenda Koltun Reuven
Address 0 0
Country 0 0
Phone 0 0
719-331-1638
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06410313