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

Not Applicable

Active, not recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Combination Product: Percutaneous Transluminal Angioplasty (PTA)

• Registration Number: NCT04475783
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Study Start: 2021-04-13
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolomus DCB group	Percutaneous Transluminal Angioplasty (PTA)	Intervention with Sirolimus-coated balloon catheter
Paclitaxel DCB group	Percutaneous Transluminal Angioplasty (PTA)	Intervention with Paclitaxel-coated balloon catheter

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 2	at 6, 12, 24, 48 months after study procedure	6-minute Walking test (6MWT)
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
Walking capacity assessment 3	at 6, 12, 24, 48 months after study procedure	Treadmill test (optional)
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
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
Walking capacity assessment 1	at 1, 6, 12, 24, 36, 48 and 60 months after study procedure	patient-self-assessment of walking distance
ABI	at discharge, 6, 12, 24 and 48 months	Ankle brachial index (ABI)

Trial Locations

Locations (26)

Medizinische Universität Graz, Klinische Abteilung für Angiologie; 🇦🇹 Graz, Austria

Universitätsklinik für Radiologie und Nuklearmedizin, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie; 🇦🇹 Wien, Austria

Gefäßpraxis im Tal; 🇩🇪 München, Germany

Klinikverbund Allgäu gGmbH, Herz- und Gefäßzentrum Oberallgäu Kempten, Klinik Immenstadt; 🇩🇪 Immenstadt Im Allgäu, Germany

Universitätsklinikum Essen, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Kardiologie und Angiologie; 🇩🇪 Essen, Germany

Marienhaus Klinikum Mainz, Klinik für Diagnostische und Interventionelle Radiologie; 🇩🇪 Mainz, Germany

University Hospital Jena; 🇩🇪 Jena, Germany

Universitätsklinikum Heidelberg, Medizinische Klinik III, Kardiologie, Angiologie und Pneumologie; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Dresden, Institut und Poliklinik für Diagnostische und Interventionelle Radiologie; 🇩🇪 Dresden, Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Angiologie; 🇩🇪 Leipzig, Germany

RoMed Klinikum Rosenheim, Diagnostische und Interventionelle Radiologie; 🇩🇪 Rosenheim, Germany

Elblandklinikum Radebeul, Gefäßzentrum; 🇩🇪 Radebeul, Germany

Helios Klinikum Krefeld, Institut für Diagnostische und Interventionelle Radiologie; 🇩🇪 Krefeld, Germany

Universitätsklinikum Münster, Klinik für Kardiologie I, Koronare Herzkrankheit, Herzinsuffizienz und Angiologie; 🇩🇪 Münster, Germany

Medical University Vienna, Universitätsklinik für Innere Medizin II, Klinische Abteilung für Angiologie; 🇦🇹 Vienna, Austria

University Heart Center Freiburg-Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Hanusch-Krankenhaus; 🇦🇹 Wien, Austria

Klinikum Klagenfurt am Wörthersee, Institut für Diagnostische und Interventionelle Radiologie; 🇦🇹 Klagenfurt, Austria

Charité Universitätsmedizin, Klinik für Radiologie; 🇩🇪 Berlin, Germany

Fürst-Stirum-Klinik Bruchsal, Klinik für Kardiologie, Angiologie, Diabetologie, Neurologie und Intensivmedizin; 🇩🇪 Bruchsal, 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

St. Franziskus-Hospital GmbH, Klinik für Gefäßchirurgie; 🇩🇪 Münster, Germany

Schön Klinik Rendsburg, Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie; 🇩🇪 Rendsburg, Germany

MEDINOS-Kliniken Sonneberg, Gefäßzentrum; 🇩🇪 Sonneberg, Germany

Kreiskrankenhaus Torgau, Abt. Innere Medizin / Angiologie; 🇩🇪 Torgau, Germany