Trial Outcomes & Findings for ClearWay Rx Readmission Registry (NCT NCT01673893)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

59 participants

Primary outcome timeframe

30 Days

Results posted on

2018-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	Readmission Results 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
Overall Study STARTED	59
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ClearWay Rx Readmission Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ST Elevation Myocardial Infarction n=43 Participants 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	Non ST Elevation Myocardial Infarction/ACS/UNSTABLE ANGINA n=16 Participants 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 n=59 Participants Total of all reporting groups
Age, Customized <50 years	6 years n=99 Participants	1 years n=107 Participants	7 years n=206 Participants
Age, Customized 50 to 65 years	24 years n=99 Participants	8 years n=107 Participants	32 years n=206 Participants
Age, Customized 65 to 75 years	9 years n=99 Participants	6 years n=107 Participants	15 years n=206 Participants
Age, Customized >= 75 Years	4 years n=99 Participants	1 years n=107 Participants	5 years n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	36 Participants n=99 Participants	13 Participants n=107 Participants	49 Participants n=206 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	No. Re-admission Within 30-days Post Pci n=59 Participants No. of Re-admission within 30-days post pci	No. of Cardiovascular Admissions Within 30-days n=59 Participants No. of Cardiovascular Admissions within 30-days: not preplanned, not elective	No. of Patients Compliant With DAPT n=59 Participants No. of patients compliant with Dual Anti Platelet Therapy
30 Day Readmissions	7 participants	3 participants	59 participants

Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deanna K. Benoit, LPN, CCRC

Cardiovascular Institute of the South Clinical Research Corporation

Phone: 985-876-0300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60