VASCADE ANTEGRADE-PVD Post-Market Registry

• ClinicalTrials.gov Identifier: NCT02948257
• Recruitment Status: Completed
• First Posted: October 28, 2016
• Results First Posted: January 18, 2020
• Last Update Posted: January 18, 2020
• Sponsor: Cardiva Medical, Inc.
• Information provided by (Responsible Party): Cardiva Medical, Inc.

Study Description

Brief Summary:

The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.

Condition or disease	Intervention/treatment
Surgical Wound	Device: Cardiva Medical VASCADE VCS

Detailed Description:

Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 52 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Official Title: Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
• Actual Study Start Date: January 19, 2017
• Actual Primary Completion Date: September 18, 2017
• Actual Study Completion Date: September 18, 2017

Groups and Cohorts

Intervention Details:

• Device: Cardiva Medical VASCADE VCS
  At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.

Outcome Measures

Primary Outcome Measures :

1. Time to Hemostasis (TTH) [ Time Frame: Procedural, usually within 15 minutes of enrollment ]
   Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
2. Major Access Site Closure-related Complications [ Time Frame: Through 30 days +/- 7 days ]
   Patient incident rate of combined major access site closure-related complications through 30 days

Secondary Outcome Measures :

1. Time to Ambulation (TTA) [ Time Frame: Prior to discharge, usually within 24 hours ]
   Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.
2. Time to Discharge (TTD) [ Time Frame: Through hospital discharge, usually within 24 hours ]
   Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
3. Device Success [ Time Frame: Procedural, usually within 15 minutes of enrollment ]
   Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.
4. Procedure Success [ Time Frame: Through 30 +/- 7 days ]
   Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
5. Minor Access Site Closure-related Complications [ Time Frame: Through 30 +/- 7 days ]
   Patient incident rate of combined minor access site closure-related complications through 30 days

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath

Criteria

Inclusion Criteria:

• Acceptable candidate for post-procedural manual compression
• Able to ambulate at least 20 feet, with or without assistance

Exclusion Criteria:

• Active systemic or cutaneous infection or inflammation
• Ipsilateral femoral arteriotomy with any of the following conditions: a) access within < or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within < or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
• Previous vascular grafts or surgery at the target vessel access site
• Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
• Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
• Femoral arterial diameter < 6 mm at access site
• Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
• Length of tissue tract, the distance between the anterior arterial wall and skin, is < 2.5 cm.

Contacts and Locations

Locations

United States, Louisiana

Cardiovascular Institute of the South

Houma, Louisiana, United States, 70360

United States, Mississippi

North MS Medical Center

Tupelo, Mississippi, United States, 38801

United States, North Carolina

Coastal Surgery Specialists

Wilmington, North Carolina, United States, 28401

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

United States, Texas

San Antonio Endovascular and Heart Institute

San Antonio, Texas, United States, 78258

Sponsors and Collaborators

Cardiva Medical, Inc.

Investigators

• Principal Investigator: Mehdi Shishehbor, MD; The Cleveland Clinic

  Study Documents (Full-Text)

Documents provided by Cardiva Medical, Inc.:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 7, 2017

More Information

Additional Information:

Publications:

Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.

• Responsible Party: Cardiva Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02948257
• Other Study ID Numbers: PTL 0502-02
• First Posted: October 28, 2016
• Results First Posted: January 18, 2020
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Keywords provided by Cardiva Medical, Inc.:

Vessel closure; Antegrade access; Femoral arteriotomy; Peripheral endovascular interventions

Additional relevant MeSH terms:

Surgical Wound; Wounds and Injuries