Clinical trial NCT04475783: Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease
Official title: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Sirolimus
Paclitaxel
Drug-Coated Balloon
Percuteanous Transaluminal Angioplasty
PPA
SFA
MagicTouch PTA
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Concept Medical Inc.
name: Vascuscience
name: CoreLab Black Forest
name: Center for Clinical Studies, Jena University Hospital
First posted: 2020-07-17
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1-randomization, parallel design, stratified by Center.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Patency rate (Absence of clinically driven target lesion revascularization)
timeFrame: one year after study procedure (PTA with medical product under investigation or comparator)
measure: Safety outcome
timeFrame: through 12 months post-procedure
Secondary outcomes:
measure: TLR rate
timeFrame: 1, 6, 12, 24, 36, 48 and 60 months after study procedure
measure: Rutherford classification
timeFrame: at 12 months after study procedure
measure: Walking capacity assessment 1
timeFrame: at 1, 6, 12, 24, 36, 48 and 60 months after study procedure
measure: Walking capacity assessment 2
timeFrame: at 6, 12, 24, 48 months after study procedure
measure: Walking capacity assessment 3
timeFrame: at 6, 12, 24, 48 months after study procedure
measure: Walking capacity assessment 4
timeFrame: at 6, 12, 24, 48 months after study procedure
measure: Duplex Ultrasound
timeFrame: post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention
measure: ABI
timeFrame: at discharge, 6, 12, 24 and 48 months
measure: Qualilty of Life Assessment
timeFrame: at 1 month, 6, 12, 24, 36, 48 and 60 months
measure: Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization
timeFrame: trough 60 months after study procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz, Klinische Abteilung für Angiologie
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie
city: Vienna
country: Austria
facility: Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie
city: Wien
country: Austria
facility: Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
city: Wien
country: Austria
facility: Hanusch-Krankenhaus
city: Bad Krozingen
country: Germany
facility: University Heart Center Freiburg-Bad Krozingen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin, Klinik für Radiologie
city: Bruchsal
country: Germany
facility: Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie
city: Flensburg
country: Germany
facility: DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Radiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie
city: Immenstadt Im Allgäu
country: Germany
facility: Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt
city: Jena
country: Germany
facility: University Hospital Jena
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie
city: Mainz
country: Germany
facility: Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie
city: München
country: Germany
facility: Gefäßpraxis im Tal
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul, Gefäßzentrum
city: Rendsburg
country: Germany
facility: Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim, Diagnostische und Interventionelle Radiologie
city: Sonneberg
country: Germany
facility: MEDINOS-Kliniken Sonneberg, Gefäßzentrum
city: Torgau
country: Germany
facility: Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie
Study officials:
affiliation: University Hospital Jena, Institute of Radiology
name: Ulf Teichgraeber, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Teichgraber U, Ingwersen M, Platzer S, Lehmann T, Zeller T, Aschenbach R, Scheinert D. Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial. Trials. 2021 Sep 28;22(1):665. doi: 10.1186/s13063-021-05631-9.