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Heart and Vascular Clinical Trials

Clinical trials are research studies involving human volunteers who are closely monitored by:

  • Doctors
  • Nurses
  • Research assistants
  • Data analysts

If you are considering participation in a clinical trial, it is important to:

  • Discuss your health and review your medical records with your cardiologist and care team to determine eligibility.
  • Ask your cardiologist to assist you in discussing the decision with family members and caregivers, so questions or concerns can be addressed.
  • Work with your doctor to sign and consent to trial treatment.
  • Remember that participation is voluntary. You may choose to or be asked to cease participation in the trial at any time.

Learn more about the University of Pittsburgh's Research Participant Registry.

» Search the US government's clinical trial database now for heart and vascular trials.

Featured Clinical Trials and Research

Nellix: A Prospective Multicenter, Single Arm and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System with Continued Access

Sponsored by: Endologix

​Who can participate ​Patients with abdominal aortic aneurysm > 5 cm
​What we'll study ​An aneurysm is caused by a weakening in the wall of the aorta. One of the accepted treatments is to place a tube (called a stent graft) inside the aneurysm via an artery in the groin. Once the stent graft is in place, the blood will flow through the stent graft instead of against the weakened part of the aorta. The stent graft stays there permanently.

This study will be performed by the Department of Vascular Surgery at UPMC Shadyside. Patient follow- up can be done at these locations:

  • UPMC Shadyside
  • UPMC Passavant
  • UPMC Monroeville

Participants can include patients over 18 years of age with an abdominal aortic aneurysm of 5cm for greater or of 4.5cm which has increased by >0.5cm within the last 6 months or exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment.  Participants are chosen based on a diagnosis of an abdominal aortic aneurysm and must meet the inclusion/exclusion criteria.

Participants who meet the eligibility criteria will be consented for participation in the trial and screened.  Screening includes a complete medical and surgical history assessment complemented by a CT scan and required blood work.  Once your physician and the study sponsor review your CT scan and agree that you are a candidate for the device, surgery can be scheduled.

All participants must be able to meet all of the follow-up requirements to be enrolled for this study.  All subjects that qualify must agree to and be willing to be evaluated at 30 days, 6 months, and annually for5 years post procedure. Participants will also be required to obtain a creatinine and hemoglobin analysis with each visit.

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

SeCure: A Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 μm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins

Sponsored by: AngioDynamics

​Who can participate

Patients with advanced venous disease

​What we'll study ​Incompetent perforating veins (IPVs) are a common cause of venous hypertension and non-healing venous ulcers of the legs. The objective of this study is to assess the Angiodynamics 400 μm fiber for ablation of incompetent perforating veins in patients with advanced venous disease. This includes skin discoloration, ulcer or healed ulcer. The goal of this procedure is to stop flow in dysfunctional perforating veins and decrease venous pressure.

TThe study will be performed by the UPMC Department of Vascular Surgery at the following three outpatient locations:

  • Magee-Womens Hospital of UPMC
  • UPMC Shadyside
  • UPMC St. Margaret

Patients over 18 years of age with severe symptomatic venous disease (CEAP class 4b-6) and absence of saphenous reflux are eligible for study screening. Patients must be ambulatory and willing to consent to the trial. Patients will undergo a specialized duplex exam to determine anatomic suitability. Patients with venous obstruction due to past or recent deep vein thrombosis (DVT) may be ineligible for the study based on the location and extent of the previous clot. Patients currently on anticoagulation medicines or with a body-mass index (BMI) over 40 are not eligible for the study.

AParticipants are chosen based on a diagnosis of an incomplete perforator vein and meet the inclusion/exclusion criteria. Participants who meet the eligibility criteria will be consented for participation in the trial and screened. Screening includes a complete medical and surgical history assessment complemented by duplex ultrasonography (DUS) scanning of the entire study limb. In addition, vein mapping, CEAP score classification, and rVCSS scoring will be assessed prior to and after treatment.

All participants must be able to meet all of the follow up requirements to be enrolled for this study. All subjects that qualify must agree to and be willing to be evaluated at 10 days, 1, 3, 6, 9 and 12 months post procedure.

​Compensation

​**Please note: Once enrolled in this study, participants will receive at no charge: Doppler ultrasound(s), vein mapping, EVLT procedures, and pregnancy testing (when applicable). All other aspects of the study will be billed to participants insurance as “standard of care.”

​Who to contact

 To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

 

Clinical Implications of Genetic Variations of Venous Stasis Ulcerations

​Who can participate ​Patients found to have venous stasis ulcers, healed venous ulcers, and/or patients 50 or older without venous disease
​What we'll study

​The primary objective of this study is to determine if there is a genetic link between venous stasis ulcers, stratify subjects according to their potential to heal, and guide levels of therapeutic interventions and preventative strategies.

This study is focusing on the following trhee classifications:

  • Group 1: active venous stasis (CEAP 6)
  • Group 2: healed venous stasis ulcer (CEAP 5)
  • Group 3: normal controls without venous disease (CEAP class 0 or 1)

Note: CEAP classification (Clinical, Etiologic, Anatomic, Pathophysiologic) is a tool that is used to determine the deree of venous insufficiency

​How we'll conduct the study

​The study will be performed by the UPMC Division of Vascular Surgery at the following five outpatient locations:

  • Magee-Womens Hospital of UPMC
  • UPMC Mercy
  • UPMC Passavant
  • UPMC Shadyside
  • UPMC St. Margaret

Participants will be chosen based on a diagnosis of venous ulcers (18 or older), healed venous ulcers (18 or older), or controls without venous disease (age 50 or older) that meet the inclusion criteria and none of the exclusion criteria. All subjects will undergo genetic profiling based on a single blood test that will be performed at the time of consent. If any abnormalities are identified on the blood test, we will notify your primary care physician.

Follow-up

Group 1 (CEAP Class 6): After consent, all participants will receive monthly follow-up as per routine clinical care to check on their wounds. No additional or extra follow-up is required for this study.

Group 2 (CEAP Class 5): After consent, all participants will receive follow-up at six months as per routine clinical care to check on their wounds. No additional or extra follow-up is required for this study.

Group 3: (CEAP 0 or 1): After consent, all participants will take part in a one-time visit. At the completion of this visit, the participant will receive a $5.00 meal ticket that can be redeemed at the hospital cafeteria in which the evaluation was performed, and validation of their parking ticket. In addition, each participant in group 3 will have a free Doppler ultrasound of their lower extremities to evaluate for venous insufficiency/reflux. No additional follow-up is needed.

Please note: there is no additional compensation for participation in this study

​Who to contact

To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu.

REVIVE-IT - Artificial Heart Research Study

​Who can participate ​100 patients were chosen from select US hospitals, including UPMC and University of Michigan
​What we'll study The National Heart, Lung, and Blood Institute and HeartWare®, a maker of left ventricular assist devices (LVADs), are sponsoring the study of earlier access to devices that support the circulation of patients with failing hearts. In REVIVE-IT, researchers will compare whether non-transplant eligible patients with heart failure less advanced than that of current LVAD recipients do better with implanted devices than with current medical therapy.

REVIVE-IT will study HeartWare’s battery-operated continuous blood flow pump that’s surgically placed within the heart and the pericardial space surrounding the heart.
​How we'll conduct the study

​REVIVE-IT is a two-part study consisting of a trial and a registry. 

The trial looks at evaluating the HeartMate II LVAS versus a control group consisting of optimal medical management. Patients will go through a series of screening visits to ensure they meet all study criteria. Once they pass the screening levels patients will be randomized (1:1) ratio to receive the HeartMate II LVAS implant or be managed with optimal medical therapy. 

They will be followed for study purposes for approximately 2 years. If a patient fails any of the screening visits he/she will be entered into the registry where information will be collected every 6 months related to their heart failure symptoms and how it is affecting their lives. These patients will be followed for approximately 2-5 years.

​Who to contact ​To learn more about this study or about participating in future clinical trials, please contact Jess Pisarcik at
412-647-4463.

 

Evaluation of the GORE TAG Thoracic Branch Endoprosthesis of in the Treatment of Proximal Descending Thoracic Aortic Aneurysms (SSB 11-02, investigational device)

Who can participate Patients with thoracic aortic aneurysms
What we'll study

The SSB 11-02 device treats thoracic aortic aneurysms, which generally occur in the elderly and can lead to a life-threatening rupture of the aorta, the largest artery in the body. Designed to seal-off a hard-to-treat section of the aorta, the device potentially provides a safe and less invasive alternative to open heart surgery.

Through thoracic branch technology and design, this device fits the unique characteristics of the descending aorta, allowing physicians to treat a subset of patients that could not be considered for total endovascular repair in the past.

Endovascular repair uses real-time x-ray and guidewires to help deliver a graft, inserted via catheter, to exclude the lesion inside the diseased aorta, making a new path for blood to flow. Through this less invasive technique, physicians can treat conditions through small incisions in the groin that might otherwise require open chest surgery.

It is hoped that the utilization of this device will reduce the need for invasive surgical procedures commonly required today, thus reducing the complications associated with treatment of this complex disease.

Who to contact To learn more about this study or about participating in future clinical trials, please contact the Division of Vascular Surgery by calling 1-855-UPMC-HVI (option 2) or email us at VascularSurgeryResearch@upmc.edu

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