Trials / Completed
CompletedNCT03705481
GRX With ReMOTE: First in Human in India
CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Corindus Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
Detailed description
Prospective, single-arm, single center, non-randomized feasibility study of the CorPath GRX POP System to examine its performance during remote angioplasty (ballooning) and stenting and patient outcomes through 48 hours post-PCI procedure hospital discharge, whichever occurs first.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Remote treatment of PCI. | To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures. |
Timeline
- Start date
- 2018-12-03
- Primary completion
- 2018-12-06
- Completion
- 2018-12-07
- First posted
- 2018-10-15
- Last updated
- 2020-01-31
- Results posted
- 2020-01-31
Locations
1 site across 1 country: India
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03705481. Inclusion in this directory is not an endorsement.