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 purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymer-free DES (Drug Eluting Stent) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymer-free DES (Drug Eluting Stent) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography. | 9 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Heart Clinic - Prince of Wales Hospital | Sydney | New South Wales | 2031 | Australia | ||
| The Prince Charles Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28104208 | Derived | Worthley SG, Abizaid A, Kirtane AJ, Simon DI, Windecker S, Brar S, Meredith IT, Shetty S, Sinhal A, Almonacid AP, Chamie D, Maehara A, Stone GW; RevElution Investigators. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC Cardiovasc Interv. 2017 Jan 23;10(2):147-156. doi: 10.1016/j.jcin.2016.10.020. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chermside |
| Queensland |
| 4032 |
| Australia |
| St. Andrew's Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Wesley Hospital / HeartCare Partners | Auchenflower | Australia |
| Flinders Medical Center | Bedford Park | 5042 | Australia |
| St. Vincent's Hospital | Darlinghurst | 2010 | Australia |
| Royal Brisbane & Women's Hospital | Herston | 4029 | Australia |
| Monash Medical Center | Melbourne | 3168 | Australia |
| Northern Hospital | Melbourne | Australia |
| Fiona Stanley Hospital | Murdoch | Australia |
| John Hunter Hospital | New Lambton | Australia |
| Royal North Shore Hospital | St Leonards | 2065 | Australia |
| Institute Dante Pazzanese of Cardiology | São Paulo | Brazil |
| National Heart Center Singapore | Singapore | Singapore |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |