PHYSICIANS / RESEARCH INFORMATION

CURRENTLY ENROLLING STUDIES

Blood Patch Study

There were 15 patients enrolled out of 25 patients that consented to the study in April, bringing the total to 205 patients. This study is looking at all CT lung/mediastinal biopsy cases, both in- and out-patient basis. Most patients scheduled for CT lung/mediastinal biopsy will/may fit the inclusion criteria. Exception to inclusion into this study are pregnant patients, pediatric patients, patients with INR greater than 1.5, patients with hereditary or acquired bleeding disorder. Patients will also be excluded if the path of the biopsy does NOT include any lung tissue.

Retrieve 2 Study

We have a total of 3 patients enrolled in the study and we are following 2 patients for the Crux IVC filter device study. However, we are actively searching for new patients still, so please let us know if you see any potential.

Overview of the Retrieve 2 Study

• The Crux VCF System is an investigational medical device used in the prevention of PE.
• The system consists of a self-expanding Nitinol filter delivered to the inferior vena cava from a single use, disposable catheter
• Primary inclusion criteria: history of PE with resistance or contraindications to anti-thrombotic therapies, recent surgery, or multi-trauma. Additional criteria include a medical condition and/or therapy which put a patient at high risk for pulmonary embolism.
• Follow up visits occur at 30, 90 and 180 days for an abbreviated physical examination and an x-ray to confirm filter positioning and status.
• The Crux VC Filter may be retrieved prior to 180 days. In the case of VC Filter retrieval, a 30 day post-retrieval follow up visit occurs.

CAROTID STENT STUDIES

We now have just 2 active carotid stent studies. Each study is looking for patients who are at high risk for carotid endarterectomy. Asymptomatic patients must have ≥ 80% stenosis and Symptomatic patients must have ≥ 50% stenosis (determined by angiography). As a reminder, stenting is not always reimbursed by Medicare and insurance if a patient is not enrolled in one of these post-market approval studies, so please give us a call if you schedule a patient for a carotid stent or see potential patients in clinic. These studies also entail that pre-procedure and post-procedure NIH stroke scale is done on patients. Stroke scales are also needed for the follow-up visits.

There were 3 carotid stenting cases enrolled and 1 screen failure for the month of April and all patients were enrolled in the CHOICE Study.

CHOICE

CHOICE is the Abbot Vascular carotid stent registry that uses the Abbott Acculink Stent and Accunet EPD. We have enrolled 3 new patients into this study for last month. There are a total of 25 patients in the study.

Sapphire WW Registry

For the month of April, there were no enrolled subjects. We have a total of 28 patients enrolled in the Sapphire registry and we have already completed all follow-up visits for all our Sapphire Study patients. This study uses the Cordis Precise Stent and the Angioguard Distal Protection Device. There hasn't been any enrollment in this study for several months now. We have very specific high risk criteria that the patient must meet in order to be eligible for enrollment into this study, so please give me a call to make sure they qualify. Give us a heads up if you are thinking of this stent for intervention purposes.

STUDIES ON FOLLOW-UP:

There are 4 studies on follow-up.

1. STROLL Study. We are still following 3 of our STROLL patients until they complete the 3-year follow up as stated in the protocol.
2. CREST Trial. We have 10 patients that we are following for this study until they complete their 10th year follow-up.
3. Zilver PTX Study. We are involved in both Phases I and II of this trial which are both 5-years long. The last follow-up visit for Zilver PTX Phase I was completed this February. We are still following up 8 patients for Phase II however, which we are on the 2nd year of.
4. Mobility Trial. We have one patient enrolled in this trial and we will be following him up for 3 years.

What's Expected for May 2011?

May 2011 will be a transition month in the research department. This being me transitioning the Clinical Research Coordinator position over to Stephanie Arthalony by mid-May in preparation for the personnel changes that will occur in June 2011. I will be working till mid-June. So let us welcome Stephanie as the new Clinical Research Coordinator!!!! However, this still means that we are in full-force mode, in fact in an "accelerated" mode since there are still some updates needed in the research dept. There is a need to update the Standard Operating Procedures Manual for the department which is currently being drafted. Of course, the usual activities will still be present such as continued screening/enrollment for the Retrieve 2 Study, Blood Patch Study, CHOICE Study and Sapphire Study; as well as continued review of the finance, regulatory, compliance and administrative aspects of the clinical trials.

Communication is CRUCIAL!! If you see a patient in the clinic or in pre-procedure that you think might qualify for any of the enrolling studies – especially established clinic patients who are having new problems – feel free to give us a call! You could reach me through my mobile number at 224-388-1542 or Stephanie Arthalony at her mobile number 309-453-9948.