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

Peripheral Artery Disease Clinical Trial

— SIRONA  

Official title:

Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04475783
• Other study ID #: ZKSJ0127
• Secondary ID: DRKS00022452
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 478
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Combination Product:
• Percutaneous Transluminal Angioplasty (PTA)
PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz, Klinische Abteilung für Angiologie	Graz
Austria	Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie	Klagenfurt
Austria	Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie	Vienna
Austria	Hanusch-Krankenhaus	Wien
Austria	Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie	Wien
Germany	University Heart Center Freiburg-Bad Krozingen	Bad Krozingen
Germany	Charité Universitätsmedizin, Klinik für Radiologie	Berlin
Germany	Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin	Bruchsal
Germany	Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie	Dresden
Germany	Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie	Essen
Germany	DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie	Flensburg
Germany	Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Radiologie	Halle (Saale)
Germany	Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie	Heidelberg
Germany	Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt	Immenstadt Im Allgäu
Germany	University Hospital Jena	Jena
Germany	Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie	Krefeld
Germany	Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie	Leipzig
Germany	Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie	Mainz
Germany	Gefäßpraxis im Tal	München
Germany	St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie	Münster
Germany	Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie	Münster
Germany	Elblandklinikum Radebeul, Gefäßzentrum	Radebeul
Germany	Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie	Rendsburg
Germany	RoMed Klinikum Rosenheim, Diagnostische und Interventionelle Radiologie	Rosenheim
Germany	MEDINOS-Kliniken Sonneberg, Gefäßzentrum	Sonneberg
Germany	Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie	Torgau

Sponsors (5)

Lead Sponsor	Collaborator
Jena University Hospital	Center for Clinical Studies, Jena University Hospital, Concept Medical Inc., CoreLab Black Forest, Vascuscience

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate (Absence of clinically driven target lesion revascularization)	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	one year after study procedure (PTA with medical product under investigation or comparator)
Primary	Safety outcome	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	through 12 months post-procedure
Secondary	TLR rate	ocurrence of Target lesion revascularization (TLR) at certain time Points	1, 6, 12, 24, 36, 48 and 60 months after study procedure
Secondary	Rutherford classification	Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients	at 12 months after study procedure
Secondary	Walking capacity assessment 1	patient-self-assessment of walking distance	at 1, 6, 12, 24, 36, 48 and 60 months after study procedure
Secondary	Walking capacity assessment 2	6-minute Walking test (6MWT)	at 6, 12, 24, 48 months after study procedure
Secondary	Walking capacity assessment 3	Treadmill test (optional)	at 6, 12, 24, 48 months after study procedure
Secondary	Walking capacity assessment 4	Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80	at 6, 12, 24, 48 months after study procedure
Secondary	Duplex Ultrasound	Duplex-defined binary restenosis (PSVR >2.4) of the target lesion	post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention
Secondary	ABI	Ankle brachial index (ABI)	at discharge, 6, 12, 24 and 48 months
Secondary	Qualilty of Life Assessment	Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25	at 1 month, 6, 12, 24, 36, 48 and 60 months
Secondary	Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization	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	trough 60 months after study procedure