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Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease (SIRONA)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04475783
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : February 28, 2022
Sponsor:
Collaborators:
Concept Medical Inc.
Vascuscience
CoreLab Black Forest
Center for Clinical Studies Jena
Information provided by (Responsible Party):
Ulf Teichgräber, Jena University Hospital

Brief Summary:

This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.

The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Combination Product: Percutaneous Transluminal Angioplasty (PTA) Not Applicable

Detailed Description:

Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the fem-oropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.

The rationale of this study is based on the hypothesis that the usage of the Sirolimus-coated Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and safety in comparison with a clinically well-established PTX coated balloon.

The objective of this prospective, randomized, multi-center, post-market study is to compare the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD pa-tients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1-randomization, parallel design, stratified by Center.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sirolomus DCB group
Intervention with Sirolimus-coated balloon catheter
Combination Product: Percutaneous Transluminal Angioplasty (PTA)
PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Active Comparator: Paclitaxel DCB group
Intervention with Paclitaxel-coated balloon catheter
Combination Product: Percutaneous Transluminal Angioplasty (PTA)
PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery




Primary Outcome Measures :
  1. Patency rate (Absence of clinically driven target lesion revascularization) [ Time Frame: one year after study procedure (PTA with medical product under investigation or comparator) ]
    patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure or restenosis with PVR > 2.4 evaluated by duplex ultrasound

  2. Safety outcome [ Time Frame: through 12 months post-procedure ]
    Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion


Secondary Outcome Measures :
  1. TLR rate [ Time Frame: 1, 6, 12, 24, 36, 48 and 60 months after study procedure ]
    ocurrence of Target lesion revascularization (TLR) at certain time Points

  2. Rutherford classification [ Time Frame: at 12 months after study procedure ]
    Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients

  3. Walking capacity assessment 1 [ Time Frame: at 1, 6, 12, 24, 36, 48 and 60 months after study procedure ]
    patient-self-assessment of walking distance

  4. Walking capacity assessment 2 [ Time Frame: at 6, 12, 24, 48 months after study procedure ]
    6-minute Walking test (6MWT)

  5. Walking capacity assessment 3 [ Time Frame: at 6, 12, 24, 48 months after study procedure ]
    Treadmill test (optional)

  6. Walking capacity assessment 4 [ Time Frame: at 6, 12, 24, 48 months after study procedure ]
    Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80

  7. Duplex Ultrasound [ Time Frame: post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention ]
    Duplex-defined binary restenosis (PSVR >2.4) of the target lesion

  8. ABI [ Time Frame: at discharge, 6, 12, 24 and 48 months ]
    Ankle brachial index (ABI)

  9. Qualilty of Life Assessment [ Time Frame: at 1 month, 6, 12, 24, 36, 48 and 60 months ]
    Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25

  10. Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization [ Time Frame: trough 60 months after study procedure ]
    Composite of freedom from all cause death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject age ≥ 18
  2. Subject has been informed on the nature of the study, the duration of the study, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
  3. Rutherford category 2-4 according to the investigator's subjective evaluation
  4. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
  5. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
  6. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 20 cm
  7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
  8. Patency of P2 and P3 segment of the popliteal artery and at least one (1) infrapopliteal artery to the ankle (< 50 % diameter stenosis) in continuity with the femoropopliteal artery
  9. Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30 % may be treated during the index procedure to ensure sufficient inflow.
  10. A guidewire has successfully traversed the target treatment segment intraluminal
  11. Vascular disease in the opposite leg that requires treatment at the time point of index procedure is allowed, but has to be treated according to randomization or with POBA.
  12. A patient can only be enrolled and randomized once with only one target lesion in the SIRONA trial. Please note that only the lesion in one limb can be treated as target lesion for index procedure.

Exclusion Criteria:

  1. Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
  2. Flow-limiting dissection after pre-dilatation
  3. Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
  4. Presence of fresh thrombus in the target lesion
  5. Presence of aneurysm in the target vessel/s
  6. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb
  7. Prior stent in the target lesion
  8. Stroke or heart attack within 3 months prior to enrollment
  9. Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure
  10. Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index procedure
  11. Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry devices
  12. Enrolled in another investigational drug, device or biologic study
  13. Life expectancy of less than one year in the investigator's opinion
  14. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, sirolimus, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
  15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
  16. Receiving dialysis or immunosuppressant therapy
  17. Pregnant or lactating females
  18. History of major amputation in the same limb as the target lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475783


Contacts
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Contact: Ulf Teichgraeber, Prof. Dr. +49 3641 ext 9 324806 ulf.teichgraeber@med.uni-jena.de
Contact: Laura Graziani, M.A. +49 3641 ext 9 324910 laura.graziani@med.uni-jena.de

Locations
Show Show 28 study locations
Sponsors and Collaborators
Jena University Hospital
Concept Medical Inc.
Vascuscience
CoreLab Black Forest
Center for Clinical Studies Jena
Investigators
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Study Director: Ulf Teichgraeber, Prof. Dr. University Hospital Jena, Institute of Radiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulf Teichgräber, Prof. Dr., Jena University Hospital
ClinicalTrials.gov Identifier: NCT04475783    
Other Study ID Numbers: ZKSJ0127
DRKS00022452 ( Other Identifier: German Registry for Clinical Trials )
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulf Teichgräber, Jena University Hospital:
Peripheral Artery Disease
Sirolimus
Paclitaxel
Drug-Coated Balloon
Percuteanous Transaluminal Angioplasty
PPA
SFA
MagicTouch PTA
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases