Therapeutic Expertise

Cardiology - Vascular Intervention

D-TARGET has a long tradition in cardiovascular research for medical devices.  We have supported the approval of many new devices as well as post marketing studies on the following devices:

•    Stents (Bare Metal and Drug Eluting)
•    EP - Ablation Systems
•    Valve Replacement
•    CRT Devices
•    Baroreflex Stimulator
•    Cardiac Assist Devices
•    Cardiac Bioprosthesis
•    Cardiac Pressure Monitoring Devices
•    Catheter (Laser and Drug Eluting)
•    Drug Eluting Balloon
•    Mechanical Reperfusion Device
•    PFO Closure Devices
•    Thoracic Endoprosthesis and Stent Grafts

D-TARGET has managed 56 cardiology medical device studies treating approximately 22,000 patients within the past 9 years.  We have also provided consulting services for an additional 20 cardiology projects and are currently supporting trials in the US and throughout Central and Eastern Europe, Scandinavia and Israel.

KOL Network

D-TARGET is currently working with notable sites and key opinion leaders in Europe and the US.

Europe:
Leiden, Zwolle, Rotterdam, Leuven, Brussels,  Geneva, Bern, Basel, Thun, Fribourg,  Leipzig, Bad Nauheim, Dresden, Berlin, Munich, Bad Segeberg, Hamburg, Bad Krozingen, Munich, Bad Oyenhausen,  Coburg, Vienna, Graz, Prague, Warsaw,  Monaco, London, Leicester, Manchester, Milano,Lugano, Rome, Madrid, Barcelona, Stockholm, Malmö, Kopenhagen, Oslo,  Rennes, Paris, Nantes, Toulouse and Bordeaux to just name a few.

US:
Boston, Philadelphia, New York, Austin, Columbus, Chicago, Oklahoma City, Cleveland, Birmingham, Charleston, Rochester, Ann Arbor, Charlottesville, San Francisco, Fresno, San Diego, Cincinnati, Denver, Los Angeles, Plano, New Haven

Leading Publications

D-TARGET is currently supporting the clinical trial activities of a post CE Mark All comers study for a leading Drug Eluting Stent manufacturer.  The study data, involving 2300 patients in 19 centers throughout Europe and Israel, will be used to obtain FDA regulatory approval. 

Timelines were challenging for such a study design, particularly to achieve database locks for the 12 & 24 month interim analyses.  Through effective site management and good relationships with key site personnel, our team of local CRAs ensured that getting data in time was achieved.  Proactive project management, progress tracking, close contact with the sites and the sponsor ensured success with the study conduct;  the 12 Month data was presented at international cardiology congresses and 24 Month data were published in THE LANCET journal.

CEC Support

D-TARGET understands the critical importance of CEC support during medical device cardiology studies.  For this reason, we appoint a dedicated CEC coordinator that continuously monitors patient’s safety data and ensures CEC events are entered into the CRF in cooperation with the CRAs and sites.  Our CEC coordinator will also prepare and reviews CEC packages before providing the full package to the clinical events committee for their review.

Cardiology (Vascular Intervention) Study & Consulting Experience details

 

Cardiovascular

 

 

 

 

 

 

Acute Myocardial Infarction

Drug Eluting Stent

Pilot

3

50

CM, PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Pilot

1

49

BS, CM, MW, PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Pilot

9

1,700

CM, MM,

PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Pivotal/ IDE

7

350

Full Service

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Pivotal

19

2,500

CM, MM,

PM, RA

Europe, Iserael

Acute Myocardial Infarction

Drug Eluting Stent

Pivotal/ IDE

8

350

CM, PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Pivotal/ IDE

54

2,950

CM, FS, MM, MW, PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Registry

9

1,121

BS, CM, MM, PM

Europe

Acute Myocardial Infarction

Drug Eluting Stent

Registry

27

4,000

CM, MM,

PM, RA

Europe

Acute Myocardial Infarction

Drug Eluting Stent

PMS

6

1,000

CM, MM,

PM, RA

Europe

Angina

Stent Catheter

Pilot

13

58

CM, PM, RA

Europe

Coronary Catheterization

Drug Eluting Guide Catheter

Pilot

7

200

Full Service

Europe

Coronary Artery Disease

Drug Eluting Stent

Pilot

30

2,500

CM, PM, RA

Global

Coronary Heart disease

Drug Eluting Stent

Pivotal

2

20

CM, MM, PM, RA

Europe

Coronary heart disease

Drug Eluting Stent

Pivotal

1

22

BS, DM, RA

Europe

 

Coronary heart disease

 

 

Drug Eluting Stent

Pivotal

9

20

CM, MM, PM. RA

Europe

Coronary heartdisease

Coronary Stent

Registry

20

1,000

CM, PM, MM, MW, QA, RA

Europe

Stent Restenosis

Laser Catheter

Pivotal

8

100

CM, MM, PM, RA

Europe

Coronary heart disease

Drug eluting Stent

Consulting

 

 

MW

Global

Coronary heart disease

Drug eluting Stent

Consulting

 

 

MM

Europe

Coronary heart disease

Drug eluting Stent

Consulting

 

 

RA

Global

 

 

Services

 

Regions

BS

CM

DB

DM

FS

IT

MM 

MW

PM

QA

RC

RA

SS

Full Service

Biostatistics

Clinical Monitoring & Management

Data Safety Monitoring Board

Data Management

Functional Sourcing

IVRS/ IWRS

Medical Management

Medical Writing

Project Management

Quality Assurance

Research Centers

Regulatory Affairs

Study Start-Up

4 or more services including BS, CM, DM & PM

NA

WE

CE

EE

AF

AP

AU

CA

ME

NO SA

 

North America

Western Europe

Central Europe

Eastern Europe

Africa

Asia/Pacific

Australasia

Central America

Middle East

Nordics

South America