Peripheral Arterial Disease Clinical Trial
— SAVEROfficial title:
Stellarex Vascular E-Registry
| NCT number | NCT02769273 |
| Other study ID # | D029260 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2016 |
| Est. completion date | December 2021 |
| Verified date | January 2022 |
| Source | Spectranetics Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1900 |
| Est. completion date | December 2021 |
| Est. primary completion date | October 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries - Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines - Age =18 years old - Life expectancy > 1 year - Is able and willing to provide written informed consent prior to enrollment in the study (as applicable) - Is able and willing to come on site or to be contacted by phone for the follow-up 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 that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Graz | Graz | |
| Austria | Krankenhaus der Barmherzigen Schwesterrn Reid | Ried im Innkreis | |
| Austria | Krankenhaus Göttlicher Heiland GmbH | Vienna | |
| Belgium | OLV Aalst | Aalst | |
| Belgium | Imelda | Bonheiden | |
| Belgium | Europe Hospital | Brussels | |
| Belgium | AZ Sint Blasius | Dendermond | |
| Belgium | UZA Antwerpen | Edegem | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Jessa Ziekenhuis Hasselt | Hasselt | |
| Belgium | AZ Groeninge | Kortrijk | |
| Belgium | H.Hart Tienen | Tienen | |
| France | 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 Sarrus teinturiers Rive Gauche | Toulouse | |
| France | Clinique Pasteur | Toulouse Cedex 3 | |
| Germany | Klinikum Arnsberg | Arnsberg | |
| Germany | Ev. Krankenhaus Königin Elisabeth Herzberge | Berlin | |
| Germany | MediClin Herzzentrum Coswig | Coswig / Sachsen Anhalt | |
| Germany | Klinikum Doebeln GmbH | Doebeln | |
| Germany | Cardioangiologisches Centrum Bethanien | Frankfurt | |
| Germany | Krankenhäuser Landkreis Freudenstadt GmbH | Freundenstadt | |
| Germany | Universitätsklinikum Halle | Halle a.d.Saale | |
| 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 | Munster | |
| Italy | Âzienda Ospedaliera Per L'emergenza Cannizzaro | Catania | |
| Italy | AZ Ospedaliera M. Mellini Chiari | Chiari | |
| Italy | Clinica Montevergine | Mercogliano AV | |
| Italy | Ospedale Civile Di Mirano | Mirano | |
| Italy | Multimedica | Sento San Giovanni (Milan) | |
| Italy | "Villa Berica" Gruppo Garofalo | Vicenza | |
| United Kingdom | The Royal Bournemouth Hospital | Bournemouth | |
| United Kingdom | North Bristol NHS Trust | Bristol | |
| United Kingdom | Stoke Mandeville Hospital | Buckinghamshire | |
| United Kingdom | "Saint George's Vascular Institute | London | |
| United Kingdom | Royal Free Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| Spectranetics Corporation |
Austria, Belgium, France, Germany, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Efficacy Endpoint | Freedom from Clinically Driven Target Lesion Revascularization | 12 months post-procedure | |
| Primary | Primary Safety Endpoint | Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and Clinically Driven Target Lesion Revascularization through 12 months post-procedure | 12 months post-procedure |
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