ClearWay Rx Readmission Registry

• Sponsor: Cardiovascular Institute of the South Clinical Research Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01673893
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Duration (Months): 31
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this registry is to determine if delivery of weight adjusted, in a large dose with either Abcixmab or Eptifibitide through the ClearWay™ RX, in patients admitted for primary coronary intervention lowers readmission rate. This is done in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and determine whether or not the patient was readmitted within 30 days, related to the index procedure.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Device: ClearWay™ Rx catheter

Detailed Description

The primary goal of this registry is to prospectively assess if delivery of weight adjusted, bolus only with either abcixmab or eptifibitide through the ClearWay™ RX in patients admitted for primary PCI lowers readmission rate in comparison to the historical control of the Medicare/Medicaid readmission database. The registry will record the use of the product during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure.

The ClearWay™ RX Local Therapeutic Infusion Catheter is a micro-porous PTFE balloon catheter designed for the localized infusion of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. The ClearWay™ RX creates a low pressure fluid layer that surrounds the balloon, allowing more effective delivery of a prescribed therapeutic agent, without excessive stress and uncontrollable mechanical disruption seen with more traditional elastomeric devices. In addition, the ClearWay™ RX is a low pressure irrigating balloon system and non-compliant balloon that limits the amount of mechanical stress on the vessel wall.

The objective of this prospective registry is to evaluate whether intracoronary (IC) delivery of Glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) during Primary Coronary Intervention (PCI) can reduce the likelihood of 30 day readmissions as a result of the original coronary intervention. Intracoronary delivery of GP IIb/IIa inhibitor Abciximab in ST Elevation Myocardial Infarction has shown to reduce myocardial infarct size, no reflow or slow flow, improve TIMI flow and Myocardial Blush Grade2,3. The ICE trial4 (N=376) compared IC delivery of GP IIb/IIa inhibitor Eptifibitide bolus only administration, bolus with maintenance infusion of Eptifibitide, to standard intravenous (IV) bolus with maintenance infusion. At 24 month follow up, the Major Adverse Coronary Events (MACE) rate was lower in the IC bolus only group (2.5%) versus IC bolus and maintenance infusion (5.8%), and IV bolus with maintenance infusion (10.8%). Further, target lesion revascularization, and readmission rates were significantly lower in the IC bolus only arm, (10.9% versus 16.8% and 28% respectively).

Study Design

• Study Type: Observational
• Actual Enrollment: 59 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: ClearWay Rx Readmission Registry
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
ST elevation myocardial infarction The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 1st Group/Cohort - ST elevation myocardial infarction	Device: ClearWay™ Rx catheter
Non-ST elevation myocardial infarction/ACS/UNSTABLE ANGINA The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 2nd Group/Cohort - Non-ST elevation myocardial infarction/ACS/Unstable Angina	Device: ClearWay™ Rx catheter

Outcome Measures

Primary Outcome Measures

1. 30 Day Readmissions [30 Days]

   Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute Coronary Syndrome (ST elevation myocardial infarction or Non ST elevation myocardial infarction) patients requiring the use of the ClearWay™ Rx local therapeutic infusion catheter for intracoronary delivery of GP IIb/IIIa inhibitor.

Exclusion Criteria:

• Patients not meeting the above inclusion criterion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Institute of the South Clinical Research Corporation	Lafayette	Louisiana	United States	70503

Sponsors and Collaborators

• Cardiovascular Institute of the South Clinical Research Corporation

Investigators

• Principal Investigator: Nick Cavros, MD, Cardiovascular Institute of the South

Study Documents (Full-Text)

None provided.

More Information

Publications

• Curtis JP, Schreiner G, Wang Y, Chen J, Spertus JA, Rumsfeld JS, Brindis RG, Krumholz HM. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of medicare patients. J Am Coll Cardiol. 2009 Sep 1;54(10):903-7. doi: 10.1016/j.jacc.2009.04.076.
• Hassan W, Al-Sergani H, Al Buraiki J, Dunn B, Al Turki F, Akhras N, Elshaer F, Nawaz M, Kharabsheh S, ElKum N. Immediate and intermediate results of intracoronary stand-alone bolus administration of eptifibatide during coronary intervention (ICE) study. Am Heart J. 2007 Aug;154(2):345-51.
• Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.
• Romagnoli E, Burzotta F, Trani C, Biondi-Zoccai GG, Giannico F, Crea F. Rationale for intracoronary administration of abciximab. J Thromb Thrombolysis. 2007 Feb;23(1):57-63. Review.
• Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.

• Responsible Party: Cardiovascular Institute of the South Clinical Research Corporation
• ClinicalTrials.gov Identifier: NCT01673893
• Other Study ID Numbers: K061680
• First Posted: Aug 28, 2012
• Last Update Posted: Nov 29, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Cardiovascular Institute of the South Clinical Research Corporation: ClearWay; Glycoprotein; Primary Coronary Intervention; Abciximab; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; Medicare; Medicaid; Registry; catheterization; readmission; Acute Coronary Syndrome; ClearwayRx Catheter
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Readmission Results
Arm/Group Description	The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. ClearWay™ Rx catheter
Period Title: Overall Study
STARTED	59
COMPLETED	59
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ST Elevation Myocardial Infarction	Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA	Total
Arm/Group Description	The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 1st Group/Cohort - STEMI: ST elevation myocardial infarction	The registry will record the use of the ClearWay™ Rx catheter during the index procedure, and assess whether or not the patient was readmitted within 30 days, related to the index procedure. 2nd Group/Cohort - NSTEMI: Non-ST elevation myocardial infarction/ACS/Unstable Angina	Total of all reporting groups
Overall Participants	43	16	59
Age, Customized (years) [Number]
<50 years	6	1	7
50 to 65 years	24	8	32
65 to 75 years	9	6	15
>= 75 Years	4	1	5
Sex: Female, Male (Count of Participants)
Female	7 16.3%	3 18.8%	10 16.9%
Male	36 83.7%	13 81.3%	49 83.1%

Outcome Measures

1. Primary Outcome

Title	30 Day Readmissions
Description	Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.

Arm/Group Title	No. Re-admission Within 30-days Post Pci	No. of Cardiovascular Admissions Within 30-days	No. of Patients Compliant With DAPT
Arm/Group Description	No. of Re-admission within 30-days post pci	No. of Cardiovascular Admissions within 30-days: not preplanned, not elective	No. of patients compliant with Dual Anti Platelet Therapy
Measure Participants	59	59	59
Number [participants]	7 16.3%	3 18.8%	59 100%

Adverse Events

Adverse Event Reporting Description	Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.
Arm/Group Title
Arm/Group Description	Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed on 7 participants with re-admissions within 30 days post pci and 3 participants who had Cardiovascular Admissions within 30-days that were not preplanned or elective. Re-admissions were captured for data purposes only, not followed.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.