Therapeutic Expertise

Cardiovascular - Vascular Intervention & PAD

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 cardiovascular 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, Frankfurt, 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.

Experience in peripheral artery disease

We are currently working with an US client on two trials in PAD, with one trial aimed to support US IDE.
We developped a very good relationship to key opinion leaders, notably in Germany with:

• Dr. Zeller / Bad Krozingen
• Prof. Andrej Schmidt / Dr. Scheinert / Leipzig
• D. Krankenberg, Hamburg
• Prof. Sievert, Frankfurt
• Prof. Torsello, Münster

Besides that we are linked to the Core Lab of Heart Center in Bad Krozingen, that is specialized on PAD study evaluations.

Stent Restenosis	Laser Catheter	Pivotal/IDE support	8	100	CM, MM, PM, RA	Europe
Treatment of calcified lesions	Laser Catheter	Feasibility	1	30	CM, PM	Europe

Cardiovascular 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
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

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 inc. BS, CM, DM & PM

NO SA

North America

Western Europe

Central Europe

Eastern Europe

Africa

Asia/Pacific

Australasia

Central America

Middle East

Nordics

South America