Not provided
Not provided
Not provided
Not provided
Patient enrollment impacted by COVID-19 pandemic and other business challenges. Patient enrollment discontinued, but follow-ups will continue according to protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellarex DCB | Experimental | Spectranetics Stellarex Drug Coated Balloon |
|
| PTA Catheter | Active Comparator | Standard Uncoated Balloon Angioplasty Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellarex DCB | Device | Intervention with the Stellarex DCB |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Major Adverse Limb Event (MALE) | Composite of major amputation or major reintervention on a per patient basis | 30 days |
| Freedom from Perioperative Death (POD) | Death on a per patient basis | 30 days |
| Patency | Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis | 6 months |
| Limb Salvage | Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically-driven target lesion revascularization | Rate of clinically-driven target lesion revascularization | 6 months |
| Major adverse event rates | Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William Gray, MD | Lankenau Heart Institute | Principal Investigator |
| Mahmood K Razavi, MD | Vascular and Interventional Specialists of Orange | Principal Investigator |
| Dierk Scheinert, MD | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital | Orange | California | 92868 | United States | ||
| Bradenton Cardiology Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PTA Catheter |
| Device |
Intervention with an uncoated Standard PTA |
|
| 6 months |
| Patency rate | Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention | 6 months |
| Bradenton |
| Florida |
| 34205 |
| United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University Hospitals, Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania | 17043 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Flinders Medical Center | Bedford Park | Australia |
| Sir Charles Gairdner Hospital | Perth | Australia |
| LKH Universitatsklinik Graz | Graz | Austria |
| Medizinische Universitat Wien | Vienna | Austria |
| Imelda Ziekenhuis | Bonheiden | Belgium |
| ZOL St. jan | Genk | Belgium |
| University Hospital Gent | Ghent | Belgium |
| Klinikum Hoschsauerland GmbH | Arnsberg | Germany |
| Universitats-Herzzentrum Freiburg-Bad Krozingen | Bad Krozingen | Germany |
| SRH Klinikum Karlsbad | Karlsbad | 76307 | Germany |
| Universitatsklink Leipzig | Leipzig | Germany |
| University Hospital of Tuebingen | Tübingen | Germany |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
Not provided
Not provided