PerQseal® Impella Early Feasibility Study

NCT04818541 | Completed DMC FDA Device

• 1 other identifier: P849-00
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closure of femoral arterial access sites created with 13 to 14 F sheaths will be studied, assessing the need for alternative therapy other than manual compression or adjunctive endovascular ballooning.

Conditions

Percutaneous Large Hole Vascular Closure

Keywords

vascular closure; arterial closure; vascular closure device; large hole percutaneous closure; large bore percutaneous closure

Outcome Measures

Primary Outcomes (2)

• Safety: Major Access Site Complications

  The primary safety endpoint is the rate of major access site complications attributable to the PerQseal® device. As per FDA definitions for Major access site complications.

  through 30 days

• Efficacy: Time to Hemostasis

  Elapsed time in minutes from PerQseal® Introducer sheath removal to first observed cessation of common femoral artery (CFA) bleeding (excluding cutaneous or subcutaneous oozing, and in the absence of a developing hematoma).

  20 minutes

Secondary Outcomes (5)

• Safety: Incidence of Minor Access Site Complications

  through 30 days

• Efficacy: PerQseal® Device Technical Success Rate

  10 minutes

• Efficacy: PerQseal® Treatment Success Rate

  through 30 days

• Efficacy: Time to Device Deployment

  20 minutes

• Efficacy: Overall Procedural Time

  4 days

Study Arms (2)

Protected Percutaneous Coronary Intervention

EXPERIMENTAL

Subjects with a femoral arteriotomy created with 13 to 14 F sheaths (arteriotomy up to approximately 18 F) and in whom an Impella device was used for PPCI. Duration of Impella use ≤ 6 hours if used for PPCI.

Device: PPCI

Cardiogenic shock

EXPERIMENTAL

Subjects with a femoral arteriotomy created with 13 to 14 F sheaths (arteriotomy up to approximately 18 F) and in whom an Impella device was used for cardiogenic shock. Duration of Impella use \> 8 hours and ≤ 4 days.

Device: Cardiogenic shock

Interventions

PPCI DEVICE

Closure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump.

Also known as: Percutaneous PerQseal device closure

Protected Percutaneous Coronary Intervention

Cardiogenic shock DEVICE

Closure of the femoral access site with PerQseal device after removal of the Impella pump.

Also known as: Percutaneous PerQseal device closure

Cardiogenic shock

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years,
• Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock,
• Duration of Impella use \> 8 hours and ≤ 4 days if used for cardiogenic shock
• Duration of Impella use ≤ 6 hours if used for PPCI.
• Impella access sheath between 13 and 14 F,
• Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

You may not qualify if:

• Evidence of systemic bacterial or cutaneous infection, including groin infection,
• Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/µl or subjects on long term anticoagulants with an INR \> 2 within 12 hours prior to index procedure,
• Significant anemia (hemoglobin \<9 g/dL or hematocrit \< 27%), within 24 hours prior to index procedure,
• Known type II heparin-induced thrombocytopenia,
• Unilateral or bilateral lower extremity amputation.
• Rest pain (e.g., Rutherford category 4 or greater), documented untreated iliac or common femoral artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,
• Known existing nerve damage in the target leg,
• Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use),
• Subject unsuitable for surgical repair of the target leg access site,
• Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure,
• Subject has undergone a percutaneous procedure of 8 F sheath or less using an absorbable or suture mediated closure device for hemostasis, in the target vessel, within the 90 days prior to index procedure,
• Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site,
• Target femoral artery diameter is less than 6 mm in diameter,
• Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up,
• Subject has been previously enrolled in this clinical study.

Sponsors & Collaborators

• Vivasure Medical Limited: lead

Study Sites (4)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Study Design

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

Model Details: Early Feasibility Study

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: June 29, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)