Comparison Between Manta and Prostar Closure Devices

Sponsor
RWTH Aachen University (Other)
Overall Status
Completed
CT.gov ID
NCT05662748
Collaborator
(none)
250
1
14.3
17.5

Study Details

Study Description

Brief Summary

Use of the closure device in patient with percutaneous transfemoral aortic valve replacement

Condition or Disease Intervention/Treatment Phase
  • Device: Transfemoral aortic valve replacement

Detailed Description

The advent of endovascular, transcatheter aortic valve replacement (TAVR), and mechanical circulatory support has offered new, minimally invasive therapeutic options that are rapidly becoming standard of care. These percutaneous transfemoral interventions require large-bore catheters and have created challenges for femoral arterial access management. Current approaches include surgical cut-down with arterial puncture under direct vision, and suture-based "pre-closure." Surgical cut-down is associated with longer procedural time, increased patient discomfort, deeper anesthesia, risk of wound complications including infection, and slower ambulation. The pre-closure technique overcomes many of the disadvantages of surgical cut-down but can be technically demanding, time consuming, and associated with a significant failure rate. Recent randomized TAVR trials have reported major vascular complications in 6% to 8% . Furthermore, a study on the 2 suture-based closure techniques for management of TAVR access reported a 20% vascular complication rate despite being used by experienced operators . Currently, the majority of access site complications result from failed arteriotomy closure . The percutaneous MANTA Vascular Closure Device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to closure of largebore arteriotomies . The MANTA VCD underwent prospective multicenter evaluation for Conformitä Europäenne (CE) mark approval in the first detailed report of outcomes achieved with a dedicated large-bore vascular closure device Contrary to the aforementioned TAVR procedures, mechanical circulatory support therapy can be extended up to several days on the intensive care ward. Data on such delayed closure with is lacking. This registry is therefore aimed to document the initial experiences of delayed closure of a femoral large bore access with vascular closure devices in patients with an TAVR device.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
250 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Mar 30, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Pro Star

patient received Pro Star Device

Device: Transfemoral aortic valve replacement
aortic valve replacement

MANTA

Patient received MANTA Device

Device: Transfemoral aortic valve replacement
aortic valve replacement

Outcome Measures

Primary Outcome Measures

  1. Safety endpoints during index hospitalisation [2018 - 2020]

    Major vascular complications,

  2. Safety endpoints during index hospitalisation ( bleeding) [2018-2020]

    life-threatining-, major bleeding

  3. Safety endpoints during index hospitalisation ( death ) [2018-2020]

    death

Secondary Outcome Measures

  1. efficacy endpoints during index hospitalisation - (hemotasis) [2018-2020]

    hemotasis in angiogram

  2. efficacy endpoints during index hospitalisation ( device failure) [2018-2020]

    device failure

  3. efficacy endpoints during index hospitalisation ( bail-out ) [2018-2020]

    need for stent-graft

Other Outcome Measures

  1. preperation time [2018-2020]

    preperation time for closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent
Exclusion Criteria:
  • Male or female aged < 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Aachen Aachen NRW Germany 52074

Sponsors and Collaborators

  • RWTH Aachen University

Investigators

  • Principal Investigator: Jörg Schröder, Universitätsklinikum Aachen Medizinische Klinik 1
  • Principal Investigator: Michael Lehrke, Universitätsklinikum Aachen Medizinische Klinik 1

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jörg Schröder, PD Dr. med Jörg Schröder, RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT05662748
Other Study ID Numbers:
  • RWTH AachenU
First Posted:
Dec 22, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jörg Schröder, PD Dr. med Jörg Schröder, RWTH Aachen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2022