Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of SiroLIMus Drug Coated Balloon Versus Non-coated Standard Angioplasty for the Treatment of Infrapopliteal Occlusions in Patients With PEripheral Arterial DiSease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Jena University Hospital
- Enrollment
- 230
- Locations
- 19
- Primary Endpoint
- composite of limb salvage and primary patency at 6 months
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This study is a prospective, interventional, multicenter 1:1 randomized trial.
The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.
Detailed Description
The purpose of this study is to assess whether efficacy of the MagicTouch® Sirolimus Coated PTA Balloon Catheter (SRL-DCB) is superior and whether safety is non-inferior to Plain Old Balloon Angioplasty (POBA) regarding treatment of high-grade stenoses ≥ 75 % in the infrapopliteal arteries (located below the P3 segment of the popliteal artery to the tibiotalar joint) in patients presenting with chronic limb-threatening ische-mia (CLTI) (Rutherford 4-6).
Investigators
Ulf Teichgräber
Principal Coordinating Investigator
Jena University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years at the time of consent.
- •Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.
- •Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses).
- •Life expectancy \> 1 year in the investigator's opinion.
- •Subject presenting with documented chronic limb-threatening ischemia (CLTI) in the target limb defined as Rutherford category 4, 5 or
- •In case of Rutherford category 5 or 6: Subjects with documented infection grade ≤ 2 according to the wound ischemia foot infection (WIfI) classification.
- •All ischemia grades according to the wound ischemia foot infection (WIfI) classifi-cation are allowed.documented infection grade ≤ 2 according to the wound ischemia foot infection (WIfI) classification.
- •7\. All ischemia grades according to the wound ischemia foot infection (WIfI) classification are allowed.
- •8\. Reference Vessel Diameter (RVD) ≥ 2 and ≤ 4.0 mm.
- •≥ 75 % stenosis or occlusion of the target vessel by visual estimate of the treating physician; no minimal lesion length required.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
composite of limb salvage and primary patency at 6 months
Time Frame: 6 months after study procedure (PTA with medical product under investigation or comparator)
composite of limb salvage and primary patency at 6 months. Primary patency is defined as absence of target lesion restenosis ≥ 75 % or re-occlusion (corresponding to PSVR \> 3.5 or no flow)as determined by duplex ultrasound without clinically driven target lesion revascularization (CD-TLR) after index procedure. Clinically driven TLR is defined as revascularization due to restenosis of ≥ 50 % in the target lesion and * Deterioration of Rutherford Class and/or * Deterioration or persistence of wounds according to the WIfI classification wound component score
Secondary Outcomes
- MALE-POD(30 days after study procedure.)
- rate of clinically-driven TVR(1, 6, 12, 24 and 36 months after study procedure.)
- TVR rate in treated target vessel and non-target vessels(1, 6, 12, 24 and 36 months after study procedure.)
- TVR rate(1, 6, 12, 24 and 36 months after study procedure.)
- Primary Patency of target and treat non-target vessel(1, 6, 24 and 36 months after study procedure.)
- Primary Patency rate(1, 6, 24 and 36 months after study procedure.)
- Secondary Patency rate(1, 6, 24 and 36 months after study procedure.)
- Secondary Patency of target and treat non-target vessel(1, 6, 24 and 36 months after study procedure.)
- Re-stenosis of >= 75% or occlusion rate(1, 6, 12, 24 and 36 months after study procedure.)
- Number of treated Non-target vessels(36 months after study procedure)
- Walking Capacity Assessment 1(1, 6, 12, 24 and 36 months after study procedure.)
- Walking Capacity Assessment 2(1, 6, 12, 24 and 36 months after study procedure.)
- Target Limb Major Amputations(1, 6, 12, 24 and 36 months after study procedure.)
- all-cause mortality(1, 6, 12, 24 and 36 months after study procedure.)
- Amputation free survival (AFS)(1, 6, 12, 24 and 36 months after study procedure.)
- Amputation free survival and resolved CLTI(1, 6, 12, 24 and 36 months after study procedure.)
- Ankle-Brachial-Index (ABI)(1, 6, 12, 24 and 36 months after study procedure.)
- Toe-Brachial-Index (TBI)(1, 6, 12, 24 and 36 months after study procedure.)
- Rutherford classification(1, 6, 12, 24 and 36 months after study procedure.)
- Primary sustained clinical improvement(1, 6, 12, 24 and 36 months after study procedure.)
- Secondary sustained clinical improvement(1, 6, 12, 24 and 36 months after study procedure.)
- EQ-5D-3L(1, 6, 12, 24 and 36 months after study procedure.)
- Wound healing(1, 6, 12, 24 and 36 months after study procedure.)
- New or recurrent wound of the target limb(1, 6, 12, 24 and 36 months after study procedure.)
- Device Success(at index procedure)
- Length of in-hospital-stay(1, 6, 12, 24 and 36 months after study procedure.)
- Major Adverse Limb Events (MALE)(1, 6, 12, 24 and 36 months after study procedure.)
- Technical Success(at index procedure)
- Procedural success(at index procedure)
- composite endpoint: patency, rate of overall-cause death and amputation-free survival(1, 6, 12, 24 and 36 months after study procedure.)
- composite endpoint: rate of all-cause death, target limb major amputation and clinically-driven TLR(1, 6, 12, 24 and 36 months after study procedure.)