VASCADE ANTEGRADE-PVD Post-Market Registry

NCT02948257 | Completed Results DMC

• 1 other identifier: PTL 0502-02
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 5

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.

Conditions

Surgical Wound

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Time to Hemostasis (TTH)

  Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.

  Procedural, usually within 15 minutes of enrollment

• Major Access Site Closure-related Complications

  Patient incident rate of combined major access site closure-related complications through 30 days

  Through 30 days +/- 7 days

Secondary Outcomes (5)

• Time to Ambulation (TTA)

  Prior to discharge, usually within 24 hours

• Time to Discharge (TTD)

  Through hospital discharge, usually within 24 hours

• Device Success

  Procedural, usually within 15 minutes of enrollment

• Procedure Success

  Through 30 +/- 7 days

• Minor Access Site Closure-related Complications

  Through 30 +/- 7 days

Interventions

Cardiva Medical VASCADE VCS DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardiva Medical, Inc.: lead

Study Sites (5)

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

North MS Medical Center

Tupelo, Mississippi, 38801, United States

Location

Coastal Surgery Specialists

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

San Antonio Endovascular and Heart Institute

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

• 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.

  PMID: 25740963 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Terry Alverson, Director of Regulatory and Clinical
• Organization: Cardiva Medical

Terry_Alverson@cardivamedical.com

408-470-7119

Study Officials

• Mehdi Shishehbor, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 28, 2016
• Study Start: January 19, 2017
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Locations

US (5)