- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436470
Treatment (Compassionate) Use of Device - PK Papyrus
June 26, 2023 updated by: Robert Starke, University of Miami
The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.
Study Overview
Status
Temporarily not available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Jackson Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.
Exclusion Criteria:
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Starke, MD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 21, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220552
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pseudoaneurysm, Carotid
-
China National Center for Cardiovascular DiseasesActive, not recruitingAortic Dissection | Aortic Intramural Hematoma | Aneurysm, Aortic Arch | Aortic Pseudoaneurysm | Aortic Ulcer, PenetratingChina
-
Rigshospitalet, DenmarkCompleted
-
Silk Road MedicalCompletedCarotid Artery Plaque | Carotid Stenosis | Carotid Artery Diseases | Carotid Atherosclerosis | Carotid DiseaseUnited States, Spain
-
Hopital de l'Enfant-JesusUnknown
-
Xuanwu Hospital, BeijingRecruitingCarotid Artery Plaque | Carotid Artery Stenting | Carotid EndarterectomyChina
-
Beijing Tiantan HospitalRecruitingCarotid EndarterectomyChina
-
University of California, DavisCompletedEndarterectomy, CarotidUnited States
-
Washington University School of MedicineTerminatedCarotid EndarterectomyUnited States
-
Shiraz University of Medical SciencesCompletedCarotid StentingIran, Islamic Republic of
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); Cedars-Sinai Medical Center and other collaboratorsRecruitingCarotid Atherosclerosis | Asymptomatic Carotid Artery Stenosis | Carotid Artery AtheromaUnited States
Clinical Trials on PK Papyrus
-
Methodist Health SystemRecruiting
-
China Medical University HospitalNational Science Council, TaiwanCompletedParkinson's Disease | Freezing of GaitTaiwan
-
Olympus Surgical Technologies EuropeWithdrawn
-
Children's Hospital of PhiladelphiaIlera HealthcareTerminatedEpilepsy | Multiple Sclerosis | Glaucoma | Cancer | Parkinson Disease | HIV/AIDS | ALS | Autism Spectrum Disorder | Sickle Cell Disease | Spasticity, Muscle | Huntington Disease | Opioid Use | Neuropathy | Terminal Illness | Inflammatory Bowel Disease (IBD) | Intractable Pain | Ptsd | Dyskinetic SyndromeUnited States
-
Smith & Nephew, Inc.CompletedBunionectomy | Hallux Valgus Repairs | Medial or Lateral Instability Repairs/Reconstructions | Achilles Tendon Repairs/Reconstructions | Midfoot Reconstructions | Metatarsal Ligament/Tendon Repairs/Reconstructions | Scapholunate Ligament Reconstructions | Lateral Epicondylitis Repair | Ulnar | Bicep Tendon...United States, Canada
-
Smith & Nephew, Inc.CompletedDeficiency of Anterior Cruciate Ligament
-
OHSU Knight Cancer InstituteOregon Health and Science University; Janssen, LP; The Leukemia and Lymphoma...TerminatedRecurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Histiocytic and Dendritic Cell Neoplasm | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Solid Neoplasm | Recurrent... and other conditionsUnited States, Puerto Rico
-
M.D. Anderson Cancer CenterCompletedMetastatic Carcinoma in the Adrenal Cortex | Stage III Adrenal Cortex Carcinoma AJCC v8 | Stage IV Adrenal Cortex Carcinoma AJCC v8 | Unresectable Adrenal Cortex CarcinomaUnited States
-
University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingTuberculosis | Coinfection | Human Immunodeficiency Virus (HIV)Ghana