For more information on any of the below listed studies, please email research@metrogr.org.
PERIPHERAL ARTERY DISEASE
LEVANT 2 Safety Registry
Condition: Peripheral Artery Disease (PAD)
The goal of this research is to learn more about the benefits of using the Lutonix Drug Coated Balloon catheter (formerly… Moxy Drug Coated Balloon catheter) and to gather more data to show it is safe when treating people with narrowed leg blood vessels.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01790243?term=Levant+2&rank=3
The goal of this research is to learn more about the benefits of using the Lutonix Drug Coated Balloon catheter (formerly… Moxy Drug Coated Balloon catheter) and to gather more data to show it is safe when treating people with narrowed leg blood vessels.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01790243?term=Levant+2&rank=3
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis - EXCITE
Condition: Peripheral Artery Disease (PAD)
The goal of this research is to show that using Excimer Laser technology with balloon angioplasty achieves superior results treating In-Stent Restenosis (ISR), compared with angioplasty alone.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01330628?term=EXCITE+ISR&rank=1
The goal of this research is to show that using Excimer Laser technology with balloon angioplasty achieves superior results treating In-Stent Restenosis (ISR), compared with angioplasty alone.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01330628?term=EXCITE+ISR&rank=1
The Chocolate Balloon Angioplasty Registry
Condition: Peripheral Artery Disease (PAD)
The purpose of the research is to collect data to learn more about how the Chocolate™ PTA Balloon Catheter is being used and to measure the outcomes of patients that are being treated for blocked blood vessels in the leg with the device.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01589042?term=Chocolate+Bar+Registry&rank=1
The purpose of the research is to collect data to learn more about how the Chocolate™ PTA Balloon Catheter is being used and to measure the outcomes of patients that are being treated for blocked blood vessels in the leg with the device.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01589042?term=Chocolate+Bar+Registry&rank=1
Condition: Peripheral Artery Disease
The purpose of this study is to provide the FDA with additional evidence confirming the safety and effectiveness of the LifeStent(R) Vascular Stent Systems.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00908947?term=CONTINUUM&rank=1
The purpose of this study is to provide the FDA with additional evidence confirming the safety and effectiveness of the LifeStent(R) Vascular Stent Systems.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00908947?term=CONTINUUM&rank=1
Cook Tibio-Pedal Registry
Condition: Peripheral Artery Disease (PAD)
The purpose of this research is to gather information on how blocked leg arteries are treated. Doctors are often able to treat blocked leg arteries by inserting catheters (small wires) into the leg artery through a small hole in the groin or upper thigh. This study will collect information about how blocked leg arteries are treated if catheters are inserted through a small hole below the knee.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01609621?term=tibiopedal+access&rank=1
The purpose of this research is to gather information on how blocked leg arteries are treated. Doctors are often able to treat blocked leg arteries by inserting catheters (small wires) into the leg artery through a small hole in the groin or upper thigh. This study will collect information about how blocked leg arteries are treated if catheters are inserted through a small hole below the knee.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01609621?term=tibiopedal+access&rank=1
A Study to Determine the Safety and Efficacy of BIOTRONIK's Astron and Pulsar Stents (BIOFLEX-I)
Condition: Peripheral Artery Disease (PAD)
The purpose of this study is to demonstrate the safety and efficacy of Biotronik’s Astron and Pulsar stents.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/study/NCT01319812?term=Biotronik&rank=22#locn
The purpose of this study is to demonstrate the safety and efficacy of Biotronik’s Astron and Pulsar stents.
Principal Investigator: Jihad Mustapha, MD
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/study/NCT01319812?term=Biotronik&rank=22#locn
HEART DISEASE
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) CANTOS
Condition: Coronary Heart Disease
The purpose of this research is to find out if a drug called Canakinumab can help people with heart disease. This study is testing the investigational use of Canakinumab. Canakinumab is approved for treatment of rare inflammatory diseases, but is not approved for use after a heart attack.
Principal Investigator: Paul J. Kovack, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01327846?term=ACZ885%2FCanakinumab&recr=Open&cond=%22Coronary+Artery+Disease%22&rank=1
CELESTIAL (Corox OTW, Endocardial, Left VEntricular STeroId LeAd, BipoLar) Post Approval Registry
Condition: Congestive Heart Failure
The purpose of this research is to confirm the long-term safety and reliability of the Corox BP LV Lead, a non-investigational lead.
Principal Investigator: Matthew Sevensma, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00810264?term=CELESTIAL&rank=1
The purpose of this research is to confirm the long-term safety and reliability of the Corox BP LV Lead, a non-investigational lead.
Principal Investigator: Matthew Sevensma, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00810264?term=CELESTIAL&rank=1
IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices
Condition: Congestive Heart Failure
The purpose of this research is to investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
Principal Investigator: Matthew Sevensma, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00559988?term=IMPACT&rank=6
The purpose of this research is to investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
Principal Investigator: Matthew Sevensma, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT00559988?term=IMPACT&rank=6
CANCER
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/ HER2-) with BRCA1/2 Mutations
CONDITION: Triple negative or BRCA + Breast Cancer
The purpose of this research is to test a new cancer treatment drug called PF-01367338 when used in combination with an FDA approved chemotherapy drug called cisplatin to see what effects (good and bad) it has on you and your cancer.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01074970?term=BRE09-146&rank=1
The purpose of this research is to test a new cancer treatment drug called PF-01367338 when used in combination with an FDA approved chemotherapy drug called cisplatin to see what effects (good and bad) it has on you and your cancer.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT01074970?term=BRE09-146&rank=1
CONDITION: Metastatic Prostate Cancer
The purpose of this research is to test the safety and effectiveness of Cabozantinib (XL 184) compared to Prednisone for metastatic prostate cancer.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01605227?term=MDV3100+COMET&rank=1
The purpose of this research is to test the safety and effectiveness of Cabozantinib (XL 184) compared to Prednisone for metastatic prostate cancer.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01605227?term=MDV3100+COMET&rank=1
CONDITION: Metastatic Renal Cell Carcinoma
The purpose of this research is to test the safety and effectiveness of an investigational cancer treatment drug called BNC105P alone or in combination with Everolimus.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01034631?term=BNC105P&rank=1
The purpose of this research is to test the safety and effectiveness of an investigational cancer treatment drug called BNC105P alone or in combination with Everolimus.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01034631?term=BNC105P&rank=1
First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma GU10-147
CONDITION: Metastatic Urothelial Cell Carcinoma
The purpose of this research is to test the safety and effectiveness of Everolimus when given alone or when given in combination with Paclitaxel.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01215136?term=GU10-147&rank=1
The purpose of this research is to test the safety and effectiveness of Everolimus when given alone or when given in combination with Paclitaxel.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01215136?term=GU10-147&rank=1
Bendamustine in Combination with Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
CONDITION: Previously Treated Multiple Myeloma
The purpose of this research is to test the safety and effectiveness of the combination of Bendamustine, Bortezomib and Pegylated Liposomal Doxorubicin on mutiple myeloma.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01177683?term=MM08-141&rank=1
The purpose of this research is to test the safety and effectiveness of the combination of Bendamustine, Bortezomib and Pegylated Liposomal Doxorubicin on mutiple myeloma.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01177683?term=MM08-141&rank=1
Study of Palifosfamide-tris in Combination with Carboplatin and Etoposide in Chemotherapy Naive Patients with Extensive-Stage Small Cell Lung Cancer (The Matisse Study)
CONDITION: Advanced Small Cell Lung Cancer
The purpose of this research is to test the safety and effectiveness of palifosfamide-tris with etoposide and carboplatin.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01555710?term=MATISSE&rank=2
The purpose of this research is to test the safety and effectiveness of palifosfamide-tris with etoposide and carboplatin.
Principal Investigator: Michael Zakem, D.O.
This study on clinicaltrials.gov: http://clinicaltrials.gov/ct2/show/NCT01555710?term=MATISSE&rank=2
