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POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study

Submitted by aschwalb on Mon, 09/25/2017 - 08:15
Study ID
00736
Participant Ages
18+
Trial Conditions New
Study Information

You are a candidate for this study if you have Carotid Artery Disease.
Your carotid arteries are a pair of blood vessels in your neck that carry blood from your heart to your head and brain. These vessels can become narrowed or blocked by a buildup of plaque called a stenosis. A stenosis may lead to a stroke, which happens when blood flow to a part of the brain is stopped. A stroke is sometimes called a “brain attack.” If blood flow is stopped for longer than a few seconds, the brain cannot get
blood and oxygen. Brain cells can die, causing permanent damage.

The most common treatment for severe carotid artery disease is a
surgery called Carotid Endarterectomy (CEA). Your surgeon will make an incision on
your neck to access the affected artery, open it and remove the plaque. Your surgeon will then close the artery and the incision in your neck using stitches.

There are situations where a CEA cannot be performed, for example if you have other health conditions that make surgery too risky. Another option is a procedure called transfemoral carotid angioplasty and stenting (CAS). This minimally invasive alternative allows your physician to complete the procedure through a tube placed into the artery in your thigh.

First, a protection device is placed next to the diseased area of the vessel, to help prevent any pieces of plaque from traveling towards your brain. Then, a small balloon is advanced to the narrowed part of your artery. Your surgeon will inflate the balloon, compressing the plaque, and then place a small elastic-like scaffold tube called a stent in order to cover the plaque and keep the artery open. Widening the narrowed
portion of the artery may reduce the risk of stroke in the future.

The TCAR Procedure

A potential complication of both surgery and stenting is a stroke during the procedure itself. Studies have shown a higher risk of stroke during stenting as compared to
surgery. The TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System is designed to reduce the risk of stroke while inserting the ENROUTE Transcarotid Stent. The TCAR procedure is performed through a small incision at your neckline just above your clavicle. This incision is much smaller than a typical CEA incision.

Your surgeon will place a tube directly into your carotid artery and connect it to a system that will direct blood flow away from your brain, to protect against plaque that may come loose reaching your brain. Your blood will flow through the system and any material will be captured in a filter. Your filtered blood will then be returned through a
second tube in your upper leg. After the stent is placed successfully, flow reversal is turned off and blood flow resumes in its normal direction.

Physician
Contact Information

Jennifer Lambert
Nurse Practitioner Division of Vascular and Endovascular Surgery
617-789-2225
Jennifer.lambert@steward.org

Purpose of Trial
If you have carotid artery disease and your physician has told you that you are at high risk for surgical treatment (carotid endarterectomy), you
may be wondering what that means and what options you have. Several factors may increase the risk of surgery, including age and medical conditions you may suffer from. If you meet one or more of these criteria, your physician may tell you that you are eligible to participate in a clinical trial for the TCAR Procedure- TransCarotid Artery
Revascularization
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Eligibility

Male and female patients at least 18 years of age with either symptomatic carotid artery stenosis equal to or greater than 50% OR asymptomatic carotid artery stenosis equal to or greater than 80% determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be:

A complete vascular evaluation is required due to may medical and anatomical inclusion and exclusion criteria.

No healthy volunteers will be considered.

Direct Oral Anticoagulants (DOACs) versus LMWH +/- Warfarin for

Submitted by aschwalb on Thu, 08/10/2017 - 14:17
Study ID
DFCI 16-406
Trial Conditions New
Study Information

Participants will be randomized (like flipping a coin) to one of two arms:

Arm 1 - anticoagulation therapy with a low molecular weight heparin (LMWH)
alone or followed by warfarin (the usual approach).
Arm 2 - anticoagulation therapy with a direct oral anticoagulant (DOAC) (the “study approach”).
All of the medications used in this study have already been FDA-approved to treat blood clots. Therapy with a DOAC is already FDA-approved for use as anticoagulation
therapy, but DOACs have not been studied extensively in patients with cancer.
This study will allow the researchers to gather information about whether
anticoagulation therapy with a LMWH alone or followed by warfarin is better, the
same, or worse than anticoagulation therapy with a DOAC in patients with
cancer.

Contact Information

Wendy Loeser RN OCN
Clinical Research
Dana-Farber Cancer Institute at
St. Elizabeth's Medical Center
736 Cambridge St
Boston, MA 02135
617-789-3385
Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
Are you a cancer patient who has recently developed a blood clot?

The purpose of this study is to compare two
different approaches to anticoagulation therapy in patients with cancer.
Phase
3
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Eligibility

 Your doctor intends you to be on anticoagulation therapy for at least 3 months.
 Your blood counts meet the study criteria

 You are 21 years of age or older

 You are willing to be randomly assigned (like a flip of a coin) to one of two groups

You may not be eligible to participate if:

 You have acute leukemia

 You have ever received or are scheduled to receive a stem cell transplant

 You are pregnant or nursing

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Submitted by aschwalb on Thu, 08/10/2017 - 14:05
Study ID
DFCI 16-727
Trial Conditions New
Study Information

This study has two study groups. Group 1 will receive the study drug, aspirin at 300 mg per day, which is a dose that is available over the counter without a prescription. Group 2 will receive a placebo, a pill that looks like the study drug, but contains no medication. Aspirin or placebo will be taken daily for 5 years. People who were recommended hormonal therapy will continue their hormonal therapy as directed.

• Visit www.abctrial.org for more information. • Contact Wendy Loeser, RN with any questions you may have.

Physician
Contact Information

Wendy Loeser RN OCN Clinical Research Dana-Farber Cancer Institute at St. Elizabeth's Medical Center 736 Cambridge St Boston, MA 02135 617-789-3385 Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
The purpose of this study is to determine if aspirin can prevent a recurrence of breast cancer or prevent the spread of breast cancer (metastatic breast cancer). Recent studies around the world have linked aspirin with a lower risk of death from cancer. This ABC Trial is the first U.S. study to test whether aspirin will keep breast cancer from recurring and reduce death from breast cancer.
Phase
3
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Eligibility

• Women or men with node positive, HER2 negative, stage II or III breast carcinoma within one year of diagnosis and free of recurrence. •If any chemotherapy and/or endocrine therapy the last dose must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed. • Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. •Participants will be encouraged to use acetaminophen for minor pain and fever. •Patients must be enrolled within 1 year after diagnosis. •Age > 18 and < 70 years of age. •Platelet count ≥ 100,000/mm3 Exclusions: •No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention. • No history of any prior stroke • No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors. • No history of atrial fibrillation or myocardial infarction. • No history of grade 4 hypertension. •No chronic (duration >30 days) daily use of oral steriods. • No known allergy to aspirin. • No other cancer of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.