Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

NCT02521948 | Completed Results

• 1 other identifier: PSD-051
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.

Conditions

Femoral Arteriotomy Closure

Keywords

MANTA; Arterial Closure Device; Large Bore Closure Device

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Major Complications

  Composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm) * Femoral artery stenosis at the access site requiring intervention * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair * Permanent access site-related nerve injury (lasting\>30 days)

  Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure

• Hemostasis Success

  Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)

  Within the first 10 minutes of cutting the MANTA suture

Secondary Outcomes (1)

• Time to Hemostasis

  Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.

Study Arms (1)

MANTA Vascular Closure Device

EXPERIMENTAL

The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.

Device: MANTA Vascular Closure Device

Interventions

MANTA Vascular Closure Device DEVICE

The MANTA device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.

MANTA Vascular Closure Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement \[TAVR\], balloon aortic valvuloplasty \[BAV\], Abdominal Aortic Aneurysm \[AAA\] stent-graft placement)
• Eligible for sheath removal in the catheterization lab
• Age ≥18 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, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
• Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure

You may not qualify if:

• Patients who are known to be pregnant or lactating
• Patients who are immunocompromised or with pre-existing autoimmune disease
• Patients who have a systemic infection or a local infection at or near the access site
• Patients requiring a re-puncture at a site previously punctured within 48 hours
• Patients with significant anemia (hemoglobin \< 6.5 mmol/l, Hct\<30)
• Patients who are morbidly obese or cachectic (BMI \>40 or \<20)
• Patients with Systolic Blood Pressure \>180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
• Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period
• Patients in whom an antegrade puncture is performed or planned
• Patients with a known bleeding disorder including thrombocytopenia (platelet count \<150 x 10\^9/L), thrombasthenia, hemophilia, or von Willebrand's disease
• Patients with a femoral artery \<6 mm in diameter, femoral artery stenosis resulting in a vessel diameter \<6 mm, or patients with severe peripheral vascular disease
• Common femoral artery with fluoroscopically visible calcium, as determined by Angio CT, precluding safe access in the opinion of the investigator
• Patients with allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
• Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease
• Patients with Sheehan Disability Scale (SDS) scores \>12

Sponsors & Collaborators

• Essential Medical, Inc.: lead

Study Sites (3)

San Raffaele Hospital

Milan, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (3)

• Ben-Dor I, Looser P, Bernardo N, Maluenda G, Torguson R, Xue Z, Lindsay J, Pichard AD, Satler LF, Waksman R. Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):119-24. doi: 10.1002/ccd.22940.

  PMID: 21681898 BACKGROUND

• Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.

  PMID: 24440678 BACKGROUND

• Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15.

  PMID: 25027520 BACKGROUND

Results Point of Contact

• Title: Director of Operations
• Organization: Essential Medical, Inc

todd@essmedclosure.com

610-557-1009

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-02

Locations

NL (2); IT (1)