Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris
Clinical Trial Evaluating the Treatment of Patients With Refractory Chronic Angina Pectoris With Low Intensity Extracorporeal Shockwave Therapy Device
1 other identifier
interventional
35
1 country
1
Brief Summary
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedApril 3, 2012
April 1, 2012
4.3 years
November 15, 2010
April 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in AP-CCS
The AP CCS Stage at the 6 months post baseline.
6 Months
Secondary Outcomes (2)
Exercise tolerance time
6 Months
Change in PET scan
6 months
Study Arms (1)
Active Shockwave Therapy
EXPERIMENTALPatients in this group receive shockwave therapy.
Interventions
Energy Density - 0.09 mJ/mm2
Eligibility Criteria
You may qualify if:
- Diagnosed with chronic stable angina pectoris.
- Documented myocardial segments with reversible ischemia
- AP CCS class of III-IV.
- Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
- Exercise tolerance time \< 10 min (modified Bruce)
- Two ETT tests results (within two weeks) averaging no more than 25% of their mean
- Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
- Signed an IRB approved informed consent form.
- Life expectancy of \> 12 months.
You may not qualify if:
- Intraventricular thrombus
- Malignancy in the area of treatment
- Severe COPD
- No smoking during the study procedure
- MI less \< 3 months prior to treatment
- Severe Valvular disease
- Child bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medispeclead
- Heart and Diabetes Center North-Rhine Westfaliacollaborator
Study Sites (1)
Heart and Diabetes Center North-Rhine Westfalia
Bad Oeynhausen, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lothar Faber, Prof. MD
Heart and Diabetes Center North-Rhine Westfalia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2010
First Posted
March 30, 2012
Study Start
January 1, 2008
Primary Completion
April 1, 2012
Study Completion
September 1, 2012
Last Updated
April 3, 2012
Record last verified: 2012-04