Shockwave Treatment for Advanced Angina in Maastricht

NCT ID: NCT01361659

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-12-31

Brief Summary

There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.

Conditions

Angina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

shockwave treatment

9 treatments in 3 months

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
• Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
• No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
• Patient's conditions stable for at least 3 months
• Life expectancy of > 12 months.

Exclusion Criteria

• Unstable angina pectoris
• Haemodynamically significant valvular heart disease
• Myocardial infarction <3 month prior randomization
• Evidence of intracardiac thrombus
• Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
• Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
• Patients who are unwilling or unable to cooperate with the study procedure.
• Age < 18 years
• Cardiac or pulmonary malignancy
• No informed consent
• Known depression

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medispec ltd.

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maastricht University Medical Center

Principal Investigators

H. Crijns, Prof Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jindra Vainer, MD

Role: CONTACT

J.Vainer@mumc.nl

+31433875106

Facility Contacts

Jindra Vainer, MD

Role: primary

J.Vainer@mumc.nl

+31433875106

Other Identifiers

07-2-008

Identifier Type: -

Identifier Source: org_study_id