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

Sponsor

Jena University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04475783

Collaborator

Concept Medical Inc. (Industry), Vascuscience (Other), CoreLab Black Forest (Other), Center for Clinical Studies Jena (Other)

478

Enrollment

Locations

Arms

85.6

Anticipated Duration (Months)

17.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

478 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1-randomization, parallel design, stratified by Center.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 :

Apr 13, 2021

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

May 31, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patency rate (Absence of clinically driven target lesion revascularization) [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
Safety outcome [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

TLR rate [1, 6, 12, 24, 36, 48 and 60 months after study procedure]
ocurrence of Target lesion revascularization (TLR) at certain time Points
Rutherford classification [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
Walking capacity assessment 1 [at 1, 6, 12, 24, 36, 48 and 60 months after study procedure]
patient-self-assessment of walking distance
Walking capacity assessment 2 [at 6, 12, 24, 48 months after study procedure]
6-minute Walking test (6MWT)
Walking capacity assessment 3 [at 6, 12, 24, 48 months after study procedure]
Treadmill test (optional)
Walking capacity assessment 4 [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
Duplex Ultrasound [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
ABI [at discharge, 6, 12, 24 and 48 months]
Ankle brachial index (ABI)
Qualilty of Life Assessment [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
Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject age ≥ 18
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.
Rutherford category 2-4 according to the investigator's subjective evaluation
Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
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
Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
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
Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30 % may be treated during the index procedure to ensure sufficient inflow.
A guidewire has successfully traversed the target treatment segment intraluminal
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.
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:

Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
Flow-limiting dissection after pre-dilatation
Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
Presence of fresh thrombus in the target lesion
Presence of aneurysm in the target vessel/s
Prior vascular surgery (including atherectomy, bypass surgery) of the target limb
Prior stent in the target lesion
Stroke or heart attack within 3 months prior to enrollment
Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure
Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index procedure
Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry devices
Enrolled in another investigational drug, device or biologic study
Life expectancy of less than one year in the investigator's opinion
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
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
Receiving dialysis or immunosuppressant therapy
Pregnant or lactating females
History of major amputation in the same limb as the target lesion

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medizinische Universität Graz, Klinische Abteilung für Angiologie	Graz	Austria	8036
2	Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie	Klagenfurt	Austria	9020
3	Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie	Vienna	Austria	A-1090
4	Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie	Wien	Austria	1090
5	Hanusch-Krankenhaus	Wien	Austria	1140
6	Universitätsklinikum Augsburg, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie	Augsburg	Germany	86156
7	University Heart Center Freiburg-Bad Krozingen	Bad Krozingen	Germany	79189
8	Charité Universitätsmedizin, Klinik für Radiologie	Berlin	Germany	12203
9	Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin	Bruchsal	Germany	76646
10	Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie	Dresden	Germany	01307
11	Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie	Essen	Germany	45147
12	DIAKO Krankenhaus gGmbH, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie	Flensburg	Germany	24939
13	Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Radiologie	Halle (Saale)	Germany	06120
14	Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie	Heidelberg	Germany	69120
15	Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt	Immenstadt Im Allgäu	Germany	87509
16	University Hospital Jena	Jena	Germany	07747
17	Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie	Krefeld	Germany	47805
18	Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie	Leipzig	Germany	04103
19	Katholisches Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie	Mainz	Germany	55131
20	Gefäßpraxis im Tal	München	Germany	80331
21	St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie	Münster	Germany	48145
22	Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie	Münster	Germany	48149
23	Elblandklinikum Radebeul, Gefäßzentrum	Radebeul	Germany	01445
24	Imland Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie	Rendsburg	Germany	24768
25	Elblandklinikum Riesa, Gefäßzentrum	Riesa	Germany	01589
26	RoMed Klinikum Rosenheim, Diagnostische und Interventionelle Radiologie	Rosenheim	Germany	83022
27	MEDINOS-Kliniken Sonneberg, Gefäßzentrum	Sonneberg	Germany	96515
28	Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie	Torgau	Germany	04860