Study
Acronym |
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|
Approval
Packets sent - Investigator/Compliance |
| Hercules |
A PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER, SINGLE-ARM CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF THE RX HERCULINK® ELITE™ RENAL STENT SYSTEM FOR THE TREATMENT OF SUBOPTIMAL POST-PROCEDURAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN ATHEROSCLEROTIC DE NOVO OR RESTENOTIC RENAL ARTERY STENOSES IN PATIENTS WITH UNCONTROLLED HYPERTENSION |
7-27-07 |
9-12-07 |
10-2-07 |
|
10-3-07 |
PFO Registry |
PFO ACCESS Registry: Patent Foramen Ovale Closure with the AMPLATZER PFO OCCLUDER in Patients with REcurrent Cryptogenic Stroke due to Presumed Paradoxical EmboliSm through a Patent Foramen Ovale who have Failed Conventional Drug Therapy. |
12-21-06 |
1-3-07 |
1-17-07 |
|
5-15-07 |
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Randomized Evaluation of Recurrent Stroke comparing PFO Closure to Established Current Standard of Care Treatment |
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|
5-15-06 |
|
Xpert Nitinol Stenting for Critically Ischemic Lower Limbs
(VIVA I/XCELL Trial) (VIVA I Physicians) |
6-12-06 |
6-19-06 |
6-22- 06
|
|
5-15-07 |
CAPTURE
2
|
A Post-Approval Study of the Guidant Acculink
Stent Systems and
Accunet Embolic Protection Systems
(Carotid RXACCULINkK/ RX ACCUNET)
Post - Approval Trial
to Uncover Unanticipated and
Rare Events-
"CAPTURE 2")
|
4/16/2006
|
5/23/2006 |
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|
6/1/2006 |
| EXACT |
Protocol: The EXACT Study: Emboshield and Xact Post Approval Carotid Stent Trial
|
1/29/2006
|
e-mail 2/6
|
e-mail 2/8
|
Per e-mail no packet necessary
|
Packets sent: sent e-mail from Dr. Cope 2/8/2006 |
| AMIHOT II |
Protocol:
The AMIHOT II Study:
A Prospective, Multi-centerRandomized
Study of Aqueous
Oxygen Therapy for
90 minutes In
Anterior Acute
Myocardial Infarction
Patients with Successful Reperfusion (VIA PCI)
<Six Hours after
Symptom Onset |
10/25/2005 |
10/27/2005 |
11/11/2005 |
|
11/14/2005 |
| CoStar II |
Protocol: Cobalt chromium Stent with Antiproliferative for Restenosis II |
9/26/2005 |
9/26/2005 |
10/14/2005 |
|
10/17/2005 |
| VIVA |
Protocol: The VivEXX
Carotid Revascularization Trial for High Surgical Risk Patients with Extracranial Carotid Artery Stenosis using the Bard ViVEXX Carotid Stent and Emboshield Bare Wire Rapid Exchange Embolic Protection System. |
9/26/2005 |
9/26/2005 |
10/14/2005 |
|
10/17/2005 |
| MAV III |
Protocol IP065, Rev B: Evaluation of the Medtronic AVE Self-Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis |
1/13/2005 |
1/19/2005 |
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| Capture-EV |
Protocol 04-715: A Post-Approval Study of the Guidant Carotid Stent Systems and Embolic Protection Systems (Carotid RX Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events-“CAPTURE”) |
11/8/04 letter date. Rec’d in CTC 11/11/04 |
N/A |
10/28/04* |
Per e-mail from Dr. Jame Cope: “as long as there is assurance that the service is a post approved study by the FDA, he does not expect a packet” |
11/11/04 |
