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All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6
To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-CLI group | Rutherford Clinical Category (RCC) 2-3 |
| |
| CLI group | critical limb ischemia，Rutherford Clinical Category (RCC) 4-6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd. | Device | All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint - non-CLI group | Freedom from clinically-driven target lesion revascularization (CD-TLR) within 12 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to recurrent clinical symptoms of PAD (increase of one Rutherford class or more) and/or drop of ankle-brachial index (≥20% or >0.15 when compared with maximum early post-procedural level). | 12 Months |
| Primary efficacy endpoint -CLI group | Freedom from clinically-driven TLR within 6 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to delayed or worsening wound healing, new or recurrent wound, or worsening Rutherford class. | 6 Months |
| Primary safety endpoint- non-CLI group | A composite of freedom from major adverse limb events and perioperative death (MALE-POD) through 30 days after index procedure. A major adverse limb event is defined as above-ankle amputation or major reintervention (ie, new bypass graft, major surgical graft revision such as a jump graft or an interposition graft, or thrombectomy/thrombolysis) of the treated limb. | 30 days |
| Primary safety endpoint- CLI group | A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Any TLR (including clinically-driven and incidental TLR) | Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of Target vessel revascularization (TVR) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Schmidt Andrej | Contact | +49-341-97 | 18770 | Andrej.Schmidt@medizin.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Schmidt Andrej | Department of Angiology, University Hospital Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halle | Recruiting | Halle | Saxony-Anhalt | Germany |
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Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure |
| 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of Target limb revascularization | Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of CD-TLR | CD-TLR at 6, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of All-cause mortality | All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure | 6 months,12 months,24 months, 36months,48 months,60months |
| Rate of Device- or procedure-related death | Device- or procedure-related death at 30 days and 6 months | 30 days, 6 months |
| Rate of Major amputation | Major amputation at 6, 12, 24, 36, 48, 60 months post procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of Technical success | Technical success defined as final in-lesion residual diameter stenosis ≤50% by angiographic visual estimate at the end of the index procedure without device malfunction. | Post procedure |
| Rate of Procedural success | Procedural success defined as technical success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or CD-TLR) prior to discharge | Post procedure |
| Change in Rutherford clinical category (target limb) | Changes in Rutherford clinical category (target limb) at 6, 12, 24, 36, 48, 60 months post-procedure compared to baseline | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of primary sustained clinical improvement | Primary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, without TLR. | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of secondary sustained clinical improvement | Secondary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, including patients with TLR | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of (Major) Amputation-free survival - CLI group | (Major) Amputation-free survival at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of Minor amputation - CLI group | Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months |
| Rate of Wound healing - CLI group | healed or not; if not, improving, stagnant,worsening | 60 months |
| New or recurrent wound of the target limb - CLI group | New or recurrent wound of the target limb | 60 months |
| Eilenburg | Recruiting | Eilenburg | Germany |
|
| Department of Angiology, University Hospital Leipzig, | Recruiting | Leipzig | Germany |
|
| Elblandklinikum Radebeul | Recruiting | Radebeul | Germany |
|
| Elblandklinikum Radebeul | Recruiting | Riesa | Germany |
|
| REGIOMED Klinikum Sonneberg | Recruiting | Sonneberg | Germany |
|
| KKH Torgau | Recruiting | Torgau | Germany |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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