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New device aims to quiet chronic chest pain

NCT ID NCT02710435

Symptom relief Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study is testing a device called the Neovasc Reducer in 400 people with chronic stable angina who have not found relief from standard treatments. The device is implanted to improve blood flow and reduce chest pain. Researchers will track symptom improvement and any serious side effects over several years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neovasc Reducer device
What this could lead to
If successful, this device could offer a new way to reduce chest pain in people with chronic angina who have few other treatment options.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device also carries risks like heart attack or arrhythmia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Mar 2016

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects with refractory angina pectoris who demonstrate objective evidence of reversible myocardial ischemia, who have limited or no options for revascularization, or subjects who have received the Reducer in the COSIRA study, or under CE Mark prior to the REDUCER-I study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria - ALL Arms: * Subject has been informed about the study and provides written informed consent prior to enrollment * Subject is willing to comply with specified follow-up evaluations Inclusion Criteria - Arm 1: * Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy * Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI) * Evidence of reversible myocardial ischemia * Left Ventricular ejection fraction (LVEF) greater than or equal to 30% * Male or non-pregnant female Inclusion Criteria - Arm 2: * Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study Inclusion Criteria - Arm 3: * Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study Exclusion Criteria - Arm 1: * Acute coronary syndrome within three months prior to enrollment * Recent successful revascularization by PCI or CABG within six months prior to enrollment * Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment * Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram \[ECG\] changes) during the 30 days prior to enrollment * Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment * Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value * Subject cannot undergo exercise tolerance test * Subject cannot undergo 6-minute walk test * Severe valvular heart disease * Subject with pacemaker electrode in the coronary sinus (CS) * Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment. * Subject having undergone tricuspid valve replacement or repair * Chronic renal failure (serum creatinine \>2 mg/dL), including subjects on chronic hemodialysis * Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year * Known severe reaction to required procedural medications * Known allergy to stainless steel or nickel * Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation * Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Angiographic Exclusion: * Mean right atrial pressure greater than 15mmHg * Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava \[SVC\]) * CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm

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Conditions

The condition(s) this trial relates to.

Angina Pectoris Angina, Stable intermediate coronary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angina pectoris Angina pectoris, stable Chronic stable angina

Contacts and locations

Locations

  • Bolognini General Hospital

    Seriate, 24068, Italy

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ, United Kingdom

  • Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie

    Essen, 45138, Germany

  • Dresden University

    Dresden, 01307, Germany

  • HFR Fribourg/University of Fribourg

    Fribourg, 1708, Switzerland

  • Hopitaux Universitaires Geneve (HUG)

    Geneva, 1205, Switzerland

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Institut Coeur Poumon

    Lille, France

  • Istituto Cardiocentro Ticino

    Lugano, 6900, Switzerland

  • Kerckhoff Klinik

    Bad Nauheim, 61231, Germany

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA, United Kingdom

  • San Raffaele Hospital

    Milan, 20132, Italy

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435CM, Netherlands

  • St. Thomas Hospital

    London, SE1 7EH, United Kingdom

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • University Giessen

    Giessen, 35392, Germany

  • University Heart Center Freiburg - Bad Krozingen

    Freiburg im Breisgau, 79106, Germany

  • University Heart Center Hamburg

    Hamburg, 20246, Germany

  • University Hospital Basel

    Basel, CH-4031, Switzerland

  • University Hospital of Brest

    Brest, France

  • University of Graz

    Graz, 8010, Austria

  • ZNA Middelheim Hospital

    Antwerp, 2020, Belgium

  • Zienkenhuis Oost-Limburg

    Genk, 3600, Belgium

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