Trial Outcomes & Findings for Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction (NCT NCT04523168)

NCT ID: NCT04523168

Last Updated: 2024-08-20

Results Overview

Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, 120 days
• Results posted on: 2024-08-20

Participant Flow

Participant milestones

Measure	Chronic Refractory Angina Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction

Baseline characteristics by cohort

Measure	Chronic Refractory Angina n=30 Participants Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
Age, Continuous	54.8 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 120 days

Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.

Outcome measures

Measure

Chronic Refractory Angina n=30 Participants Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.

Change in Coronary Flow Reserve (CFR)

3.04 ratio Standard Deviation 1.06

SECONDARY outcome

Timeframe: 120 days

The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire with 5 different subscales - physical limitations, angina stability, angina frequency, treatment satisfaction and quality of life. Each subscale score ranges from 0 to 100, where higher scores indicate better health outcomes.

Outcome measures

Measure	Chronic Refractory Angina n=30 Participants Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
Seattle Angina Questionnaire (SAQ) Angina stability score	67.5 score on a scale Standard Deviation 28.7
Seattle Angina Questionnaire (SAQ) Angina frequency score	49.9 score on a scale Standard Deviation 31.3
Seattle Angina Questionnaire (SAQ) Treatment satisfaction score	81.2 score on a scale Standard Deviation 17.3
Seattle Angina Questionnaire (SAQ) Quality of life score	54.7 score on a scale Standard Deviation 28.4
Seattle Angina Questionnaire (SAQ) Physical limitation score	62.4 score on a scale Standard Deviation 26.8

SECONDARY outcome

Timeframe: Baseline, 120 days

The Canadian Cardiovascular Society (CCS) Angina Class symptom scale classifies anginal symptoms. Scores range from 1 (best; everyday, regular, physical activity does not cause angina) to 4 (worst; unable to do any regular physical activity without discomfort, anginal symptoms may be present at rest).

Outcome measures

Measure

Chronic Refractory Angina n=30 Participants Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.

Change in Canadian Cardiovascular Society (CCS) Angina Class

2.40 score on a scale Standard Deviation 1.10

Adverse Events

Chronic Refractory Angina

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure

Chronic Refractory Angina n=30 participants at risk Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.

Cardiac disorders Wire related perforations

6.7% 2/30 • Number of events 2 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.

Other adverse events

Measure	Chronic Refractory Angina n=30 participants at risk Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. The Neovasc Reducer™ System: A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
Gastrointestinal disorders Vomiting/Nausea/Reflux	23.3% 7/30 • Number of events 10 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Headache	13.3% 4/30 • Number of events 4 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Shortness of breath	10.0% 3/30 • Number of events 7 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Fever/chills/diarrhea	3.3% 1/30 • Number of events 1 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
Infections and infestations Infection	20.0% 6/30 • Number of events 6 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders General joint pain	26.7% 8/30 • Number of events 9 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Lightheaded/dizzy/sycope	13.3% 4/30 • Number of events 4 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
Cardiac disorders Chest pain	23.3% 7/30 • Number of events 9 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Bruising	10.0% 3/30 • Number of events 3 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
General disorders Inflammation	10.0% 3/30 • Number of events 3 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
Cardiac disorders Irregular heart rate	13.3% 4/30 • Number of events 4 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.
Cardiac disorders Low blood pressure	6.7% 2/30 • Number of events 2 • Adverse events were collected for each participant from time of enrollment through four months following device implant, for a total of approximately five months.

Additional Information

Dr. Amir Lerman

Mayo Clinic

Phone: 507-255-2446

Email: lerman.amir@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place