MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study

Completed · Not applicable

Conditions studied: Femoral Arteriotomy Closure

In brief

Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.

Key facts

Study ID

NCT02908880

Run by

Essential Medical, Inc.

People needed

263

Starts

2016-12-01

Expected to finish

2017-12-01

Last updated by the study team

2019-09-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use)
• Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
• Eligible for sheath removal in the catheterization lab
• Age ≥21 years
• Understand and sign the study specific written informed consent form
• Able and willing to fulfill the follow-up requirements
• In the investigator's opinion, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial

You may not qualify if…

• Known to be pregnant or lactating
• Immunocompromised or with pre-existing autoimmune disease
• Systemic infection or a local infection at or near the access site
• Significant anemia (hemoglobin <10 g/DL, hematocrit <30%)
• Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
• Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
• Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
• Femoral artery puncture in target groin within the prior 14 days
• Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
• Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation
• Patients who are not mobile and are confined to a wheelchair or bed
• NYHA class IV heart failure
• Patients who have already participated in the IDE study
• Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
• Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease

Where it is running

• San Diego VA Medical Center — San Diego, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Evanston Hospital — Evanston, Illinois, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• Henry Ford — Detroit, Michigan, United States
• St. Luke Hospital (Mid America Heart) — Kansas City, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Lankenau Heart Group — Wynnewood, Pennsylvania, United States
• Avera Heart Hospital — Sioux Falls, South Dakota, United States
• Wellmont Holston Valley Hospital — Kingsport, Tennessee, United States
• Houston Methodist — Houston, Texas, United States
• St. Luke's Hospital - Texas Heart — Houston, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• CAMC Memorial Hospital — Charleston, West Virginia, United States
• St. Paul's Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.