NCT01205893

Brief Summary

The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
6 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

September 13, 2010

Last Update Submit

November 22, 2013

Conditions

Refractory Angina

Outcome Measures

Primary Outcomes (1)

  • Canadian Cardiovascular Society Angina Score

    A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups

    6 months

Secondary Outcomes (9)

  • Technical success

    24 hours

  • Procedural success

    24 hours

  • Periprocedural Serious Adverse Event:

    30 days

  • Periprocedural Serious Adverse Event

    30 days

  • Major Adverse Events

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Reducer

EXPERIMENTAL

Implant Reducer

Device: Neovasc Reducer

Control

SHAM COMPARATOR

No treatment

Device: Control

Interventions

Neovasc ReducerDEVICE

Implantation of the Reducer

Reducer
ControlDEVICE

Control - No device implanted

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is older than 18 years of age
  • Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
  • Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
  • Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
  • Left ventricular ejection fraction greater than 25%
  • Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
  • Patient understands the nature of the procedure and provides written informed consent prior to enrollment
  • Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone

You may not qualify if:

  • Recent (within three months) acute coronary syndrome
  • Recent (within six months) successful PCI or CABG
  • Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
  • De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
  • Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
  • 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
  • Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
  • Severe valvular heart disease
  • Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
  • Patient having undergone tricuspid valve replacement or repair
  • Chronic renal failure (serum creatinine \>2 mg/dL), including patients on chronic hemodialysis
  • Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
  • Contraindication to required study medications that cannot be adequately controlled with pre-medication
  • Known allergy to stainless steel or nickel
  • Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

ZNA Middelheim Hospital

Antwerp, 2020, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

UMC Utrecht

Utrecht, 3584, Netherlands

Location

Central Hospital Kristianstad

Kristianstad, 85, Sweden

Location

Royal Infirmary of Bradford

Bradford, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

King College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (3)

  • Jolicoeur EM, Verheye S, Henry TD, Joseph L, Doucet S, White CJ, Edelman E, Banai S. A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina. Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21.

    PMID: 32719097DERIVED

  • Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.

    PMID: 25651246DERIVED

  • Jolicoeur EM, Banai S, Henry TD, Schwartz M, Doucet S, White CJ, Edelman E, Verheye S. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials. 2013 Feb 15;14:46. doi: 10.1186/1745-6215-14-46.

    PMID: 23413981DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Verheye, MD

    ZNA Middelheim Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

SE(1)DK(1)BE(2)GB(4)CA(2)NL(1)