Trial record 1 of 15 for:
Open Studies | Heart Diseases | UCSD OR UC San Diego OR VA San Diego
Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions (PRECISION)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Corindus Inc.
Sponsor:
Corindus Inc.
Information provided by (Responsible Party):
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT01917682
First received: August 2, 2013
Last updated: February 2, 2015
Last verified: February 2015
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Purpose
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Procedure: CorPath-assisted Percutaneous Coronary Intervention |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort |
| Target Follow-Up Duration: | 3 Days |
| Official Title: | A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions |
Resource links provided by NLM:
Further study details as provided by Corindus Inc.:
Primary Outcome Measures:
- Clinical Success [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ] [ Designated as safety issue: No ]Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
Secondary Outcome Measures:
- In-hospital Major Adverse Coronary Events (MACE) [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ] [ Designated as safety issue: Yes ]The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.
- Adverse Events [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ] [ Designated as safety issue: Yes ]All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.
Other Outcome Measures:
- Overall Procedure Time [ Time Frame: During procedure ] [ Designated as safety issue: No ]Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
- PCI Procedure Time [ Time Frame: During procedure ] [ Designated as safety issue: No ]Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
- Fluoroscopy and/or X-Ray Time [ Time Frame: During procedure ] [ Designated as safety issue: No ]As recorded by an X-Ray System utilized during the procedure.
- Patient Radiation Exposure [ Time Frame: During procedure ] [ Designated as safety issue: No ]DAP (dose-area-product) and cumulative dose as recorded during the procedure.
- Contrast Fluid Volume [ Time Frame: During procedure ] [ Designated as safety issue: No ]No additional description
- Number of Conversions to Manual [ Time Frame: During procedure ] [ Designated as safety issue: No ]The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.
- Measurement of Lesion and Stented Segment Length [ Time Frame: During procedure ] [ Designated as safety issue: No ]
- Visual estimate by clinical operator prior to delivery of PCI device(s).
- CorPath 200 System measurement of the segment planned for treatment and length of deployed stent.
- Quantitative Coronary Angiography (QCA) of stented segment length
| Estimated Enrollment: | 2000 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study Cohort
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
|
Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Other Name: Robotic-assisted Percutaneous Coronary Intervention
|
Detailed Description:
This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).
Criteria
Inclusion Criteria:
- Age >18 years.
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
- The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
- Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
- Failure/inability/unwillingness to provide informed consent.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917682
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917682
Contacts
| Contact: Chris Cain, VP, Clinical Affairs | (508) 653-3335 ext 202 | chris.cain@corindus.com |
Locations
| United States, California | |
| UC San Diego Medical Center | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Ehtisham Mahmud, MD emahmud@ucsd.edu | |
| Principal Investigator: Ehtisham Mahmud, MD | |
| Sub-Investigator: Mitul Patel, MD | |
| United States, Colorado | |
| Valley View Hospital | Recruiting |
| Glenwood Springs, Colorado, United States, 81601 | |
| Contact: Richelle (Shelley) Reed, RN 970-384-7282 richelle.reed@vvh.org | |
| Principal Investigator: Frank A. Laws, MD | |
| Sub-Investigator: Kimberly Johnson, NP | |
| United States, Florida | |
| Orlando Regional Medical Center | Not yet recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Vijaykumar Kasi, MD vijaykasimd@gmail.com | |
| Principal Investigator: Vijaykumar Kasi, MD | |
| United States, Georgia | |
| Northeast Georgia Heart Center | Recruiting |
| Gainesville, Georgia, United States, 30501 | |
| Contact: Donna Patrick, RN 678-989-5001 dpatrick@ngheartcenter.com | |
| Principal Investigator: Mark Leimbach, MD | |
| Sub-Investigator: Pradyumna Tummala, MD | |
| Sub-Investigator: Jeffrey Marshall, MD | |
| United States, Massachusetts | |
| St. Elizabeth's Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02135 | |
| Principal Investigator: Joseph P. Carrozza, MD | |
| United States, Michigan | |
| Detroit Medical Center | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: Theodore Schreiber, MD | |
| Spectrum Health Hospital Group | Not yet recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Jennifer Schuitema, MA 616-391-6660 Jennifer.Schuitema@spectrumhealth.org | |
| Principal Investigator: David Wohns, MD | |
| United States, New York | |
| St. Joseph's Hospital Center | Recruiting |
| Liverpool, New York, United States, 13088 | |
| Contact: Christine Lastinger, RN 315-448-6215 clastinger@sjhcardiology.org | |
| Principal Investigator: Ron Caputo, MD | |
| Sub-Investigator: Michael Fischi, MD | |
| Sub-Investigator: Ayman Iskander, MD | |
| Sub-Investigator: Alan Simons, MD | |
| Columbia University Medical Center/New York-Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Andy Morales 212-342-4357 am2513@cumc.columbia.edu | |
| Principal Investigator: Jeffrey Moses, MD | |
| Sub-Investigator: Ali Aboufares, MD | |
| Sub-Investigator: Tamim Nazif, MD | |
| Sub-Investigator: Manish Parikh, MD | |
| United States, North Carolina | |
| Carolinas Medical Center | Not yet recruiting |
| Charlotte, North Carolina, United States, 28203 | |
| Contact: Paul Campbell, MD paul.campbell@carolinashealthcare.org | |
| Principal Investigator: Paul Campbell, MD | |
| United States, Ohio | |
| University Hospitals Case Medical Center | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Hiram Bezerra, MD hiram.bezerra@UHhospitals.org | |
| Principal Investigator: Hiram Bezerra, MD | |
| United States, South Dakota | |
| Sanford Health | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| Contact: Amy Wittrock 605-312-2346 amy.wittrock@sanfordhealth.org | |
| Principal Investigator: Tomasz Stys, MD | |
| Sub-Investigator: Adam Stys, MD | |
| Sub-Investigator: Marian Petrasko, MD | |
Sponsors and Collaborators
Corindus Inc.
Investigators
| Principal Investigator: | Giora Weisz, MD | Columbia University Medical Center/New York-Presbyterian Hospital | |
| Study Director: | Chris Cain | VP, Clinical Affairs |
More Information
Additional Information:
No publications provided
| Responsible Party: | Corindus Inc. |
| ClinicalTrials.gov Identifier: | NCT01917682 History of Changes |
| Other Study ID Numbers: | PRECISION CorPath Registry |
| Study First Received: | August 2, 2013 |
| Last Updated: | February 2, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Corindus Inc.:
|
robotic-assisted PCI coronary intervention CorPath PRECISION Registry PCI angioplasty |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Disease Coronary Disease |
Myocardial Ischemia Arteriosclerosis Heart Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015