Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
The study will recruit approximately 600 subjects treated for PAD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarex(TM) Rotational Excisional Atherectomy System | Other | Subjects treated with RotarexTM Rotational Excisional Atherectomy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarex(TM) Rotational Excisional Atherectomy System | Device | Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure. | Immediate Post Index Procedure |
| Freedom from major complications | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure | 30 days post index procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrija Sharma, PhD | Contact | 19014578360 | adrija.sharma@bd.com | |
| Talar Saber | Contact | talar.saber@bd.com |
| Name | Affiliation | Role |
|---|---|---|
| Prakash Krishnan, MD, FACC | The Icahn School of Medicine, The Mount Sinai Health System | Principal Investigator |
| Todd L Berland, MD, FACS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiology and Imaging Specialists | Recruiting | Lakeland | Florida | 33805 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vital Heart and Vein | Recruiting | Humble | Texas | 77338 | United States |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |