Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01635881 | Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter | PHASE3 | COMPLETED | 60 | — | — | Jul 1, 2012 | Dec 1, 2012 | Nov 6, 2013 | 1 | United States |
Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure
| Arm | Type | Description |
|---|---|---|
| Emerge | EXPERIMENTAL | Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter |
| Name | Type | Description |
|---|---|---|
| Emerge™ 1.20 mm PTCA Dilatation Catheter | DEVICE | The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. |
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index proc...