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Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | RCC 2-3 |
| |
| Cohort 2 | RCC 4-6 (CLI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Transluminal Angioplasty | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint Cohort 1 - RCC 2-3: | Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure. | 12 months post-procedure |
| Primary Safety Endpoint-Cohort 1 - RCC 2-3 | Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure. | 30 days post-procedure - 12Month post procedure |
| Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI) | Freedom from CD-TLR at 6 months post-procedure. | 6 Months post procedure |
| Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI) | Freedom from Composite MALE and POD through 30 days | 30days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3 |
|
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Inclusion Criteria:
Exclusion Criteria:
Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion
Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
Patients with severe disease of foot circulation defined as:
Patients confined to bed that are completely non ambulatory
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Patients with symptomatic stenosis of the superficial femoral artery and/or popliteal artery intended to be treated with a Percutaneous Transluminal Angioplasty using the Stellarex OTW Drug -Coated Balloon
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | Austria | ||||
| Krankenhaus der Barmherzigen Schwesterrn Reid |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567024 | Derived | Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30. |
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| as specified in the description |
| Rate and Freedom-from-Cohort 2 - RCC 4-6 | All-cause mortality at 6, 12, 24 and 36 months post- procedure
| As specified in the description |
| Ried im Innkreis |
| Austria |
| Krankenhaus Göttlicher Heiland GmbH | Vienna | Austria |
| UZA Antwerpen | Edegem | Edegem | 2650 | Belgium |
| OLV Aalst | Aalst | Belgium |
| Imelda | Bonheiden | Belgium |
| Europe Hospital | Brussels | Belgium |
| AZ Sint Blasius | Dendermonde | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| Jessa Ziekenhuis Hasselt | Hasselt | Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| H.Hart Tienen | Tienen | Belgium |
| Clinique Générale Annecy | Annecy | France |
| Clinique Rhone Durance | Avignon | France |
| Clinique Saint Augustin | Bordeaux | France |
| Clinique Tivoli | Bordeaux | France |
| Clinique Médipole De Savoie | Challes-les-Eaux | France |
| Grand Hôpital de l'Est Francilien - Site de Marne la Vallée | Jossigny | France |
| Groupe hospitalier Saint Joseph | Paris | France |
| Polyclinique de la Baie | Saint-Martin-des-Champs | France |
| Clinique Pasteur | Toulouse | France |
| Clinique Sarrus teinturiers Rive Gauche | Toulouse | France |
| Klinikum Arnsberg | Arnsberg | Germany |
| Ev. Krankenhaus Königin Elisabeth Herzberge | Berlin | Germany |
| MediClin Herzzentrum Coswig | Coswig | Germany |
| Klinikum Doebeln GmbH | Döbeln | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| Krankenhäuser Landkreis Freudenstadt GmbH | Freudenstadt | Germany |
| Universitätsklinikum Halle | Halle | Germany |
| Asklepios Klinikum Harburg | Hamburg | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Städtisches Klinikum Karlsruhe gGmbH | Karlsruhe | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Saint Vincenz Hospital | Limburg | Germany |
| St. Franziskus-Hospital GmbH | Münster | Germany |
| Âzienda Ospedaliera Per L'emergenza Cannizzaro | Catania | Italy |
| AZ Ospedaliera M. Mellini Chiari | Chiari | Italy |
| Clinica Montevergine | Mercogliano | Italy |
| Ospedale Civile Di Mirano | Mirano | Italy |
| Multimedica | Sesto San Giovanni | Italy |
| "Villa Berica" Gruppo Garofalo | Vicenza | Italy |
| The Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| North Bristol NHS Trust | Bristol | United Kingdom |
| Stoke Mandeville Hospital | Buckingham | United Kingdom |
| "Saint George's Vascular Institute | London | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| 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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