Coronary Microvascular DysfunctionReducerNCT04523168

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

A study testing The Neovasc Reducer™ System in people with Coronary Microvascular Dysfunction, run by Amir Lerman at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Microvascular Dysfunction
What is being tested?: The Neovasc Reducer™ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2021to 28 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age >18
Able to provide written informed consent and willing to participate in all required study follow-up assessments
Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25

Who cannot join

Recent (within 3 months) acute coronary syndrome
Patients with prior coronary artery bypass surgery
Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
Obstructive CAD on coronary angiography (>70% stenosis or 50-70% stenosis with iFR<0.89 or FFR<0.8 in epicardial artery)
Inability to perform invasive coronary flow evaluation and/or measure CFR and IMR in the LAD

Show all 23Show fewer

Severe valvular heart disease
LVEF<30%
Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
Patient with a pacemaker electrode in the CS
Mean right atrial pressure >15 mmHg
Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava (SVC) as demonstrated on angiogram
CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram
Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
Tricuspid valve replacement or repair (tissue or mechanical)
Chronic renal failure (serum creatinine >2mg/dL), and or on chronic hemodialysis
Moribund, or with comorbidities limiting life expectancy to less than one year
Known severe reaction to required procedural medication
Known allergy to stainless steel or nickel
Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation
Participation in another ongoing investigational trial
Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
Inmates

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction

Conditions: Coronary Microvascular Dysfunction
Being tested: The Neovasc Reducer™ System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Neovasc Reducer™ SystemDevice
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.

Study groups in NCT04523168
Study group	Role	What they receive
Chronic Refractory Angina	Experimental	Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory. Receives: Device: The Neovasc Reducer™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Coronary Flow Reserve (CFR)
Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.
Measured: Baseline, 120 days

Secondary outcomes (2)

Seattle Angina Questionnaire (SAQ)
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.
Measured: 120 days
Change in Canadian Cardiovascular Society (CCS) Angina Class
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).
Measured: Baseline, 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 202128 Jul 2023

First posted21 Aug 2020
Study start28 Jun 2021
Primary completion28 Jul 2023
Study completion28 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04523168
Sponsor's protocol ID: 20-006386
Acronym: Reducer
Status last verified: Jul 2024
First submitted: 19 Aug 2020
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
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All Coronary Microvascular Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
ClinicalTrials.gov ID: NCT04523168
Acronym / sponsor ID: Reducer / 20-006386
Conditions: Coronary Microvascular Dysfunction
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Amir LermanUniversity, hospital or other
Study start: 28 Jun 2021 (actual)
Primary completion: 28 Jul 2023 (actual)
Study completion: 28 Jul 2023 (actual)
First posted: 21 Aug 2020 (actual)
Results: Posted 20 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Chronic Refractory Angina	Experimental	Device: The Neovasc Reducer™ SystemSubjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age >18
Able to provide written informed consent and willing to participate in all required study follow-up assessments
Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25

Key exclusion criteria (23 listed)

Recent (within 3 months) acute coronary syndrome
Patients with prior coronary artery bypass surgery
Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
Obstructive CAD on coronary angiography (>70% stenosis or 50-70% stenosis with iFR<0.89 or FFR<0.8 in epicardial artery)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Neovasc Reducer™ SystemA 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.	Device	Chronic Refractory Angina

Primary outcome

Change in Coronary Flow Reserve (CFR)
Time frame: 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.

2 secondary outcomes

Seattle Angina Questionnaire (SAQ)
Time frame: 120 days
Change in Canadian Cardiovascular Society (CCS) Angina Class
Time frame: Baseline, 120 days

Results and safety

Results posted to the registry on 20 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chronic Refractory Angina	30	30

Primary outcome: Change in Coronary Flow Reserve (CFR)

Time frame: Baseline, 120 days. Mean (Standard Deviation). Unit: ratio

Measure	Chronic Refractory Angina n = 30
Value	3.04 (1.06)

Chronic Refractory Angina: p = 0.0137, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Refractory Angina	2 of 30 (6.7%)	16 of 30 (53.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Coronary Microvascular Dysfunction

Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amir Lerman principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Neovasc Reducer™ System in people with Coronary Microvascular Dysfunction, run by Amir Lerman at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Coronary Flow Reserve (CFR) (time frame: Baseline, 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.