PPCI for Percutaneous Large Hole Vascular Closure

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Buffalo, Buffalo, NY
PPCI - Device
Eligibility
18+
All Sexes
Eligible conditions
Percutaneous Large Hole Vascular Closure

Study Summary

This study is evaluating whether the PerQseal device is safe and effective for closure of femoral arterial access sites created with 13 to 14 F sheaths.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether PPCI will improve 2 primary outcomes and 5 secondary outcomes in patients with Percutaneous Large Hole Vascular Closure. Measurement will happen over the course of 4 days.

10 minutes
Efficacy: PerQseal® Device Technical Success Rate
20 minutes
Efficacy: Time to Device Deployment
Efficacy: Time to Hemostasis
4 days
Efficacy: Overall Procedural Time
through 30 days
Efficacy: PerQseal® Treatment Success Rate
Safety: Incidence of Minor Access Site Complications
Safety: Major Access Site Complications

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Protected Percutaneous Coronary Intervention

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. PPCI is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Protected Percutaneous Coronary Intervention
Device
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.
Cardiogenic shock
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through 30 days for reporting.

Closest Location

University of Buffalo - Buffalo, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Baseline

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of percutaneous large hole vascular closure?

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The signs of this lesion may disappear within 1-2 days. However the most effective treatment for this lesion is embolisation. It is important to know the signs and symptoms of this problem.

Unverified Answer

What are common treatments for percutaneous large hole vascular closure?

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Small-diameter vascular grafts are associated with superior outcomes to bare-metal prostheses of similar length and in equal-balanced cohorts. Percutaneous techniques may be associated with an overall improved long-term outcome, as well as decreased early and late reintervention rates.

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Can percutaneous large hole vascular closure be cured?

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Patients with chronic venous insufficiency that will require more than one closure for a successful outcome may need to reconsider the use of this technique in the management of their condition.

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What causes percutaneous large hole vascular closure?

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In a recent study, findings confirmed that the application of topical hemostatic agents prior to percutaneous closure of PHVCS has no protective effect on the PHVCS closure.

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How many people get percutaneous large hole vascular closure a year in the United States?

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Percutaneous large hole vascular closure is common in the United States. It appears to affect women as often as men. Most are white, but people of African descent are especially vulnerable to its adverse effects.

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What is percutaneous large hole vascular closure?

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The primary objective of the research was met. The percutaneous large hole vascular closure procedure appears safe and efficient. The method may serve as an alternative in the procedure of percutaneous closure of large hole in the femoral aneurysms.

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How serious can percutaneous large hole vascular closure be?

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Percutaneous large-site VA closure of a thoracoabdominal aortic shunt in experienced hands has a low rate of perioperative complications from a thoracic perspective, and can be performed safely in a thoracic setting with an acceptable risk of early or late closure of the shunt.

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Who should consider clinical trials for percutaneous large hole vascular closure?

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Patients with CHVCA will benefit from large hole vascular closure in a high proportion. However, a higher proportion of patients will only be treated by conventional surgery or other therapeutic methods. Therefore, CHVCA should be included in the national or international vascular treatment guidelines.

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What are the latest developments in ppci for therapeutic use?

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A small pore size (<0.1 mm) is associated with an increased rate of major procedural complications and procedural death. The pore size of the closure device, and/or the distance from the skin surface at the implantation site, appear to impact the rate of procedural complications only.

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What is the average age someone gets percutaneous large hole vascular closure?

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Based on data from this review, the average age of someone who undergoes PCVLVC is 65.5 years. The average age of the patient is 71.3 years at the time of percutaneous closure.

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Is ppci safe for people?

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We found no difference in the occurrence of adverse effects between PPVI with and without PPHA. We observed statistically significant higher rates of procedure-related vascular interventions and peri-procedural hemorrhagic complications with PPHA. PPHA, on the other hand, was significantly less costly. Using the cost-effectiveness model presented in this article, percutaneous closure for type I and type IIa PDA using small sheaths is economically justified.

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How does ppci work?

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Peripheral peritoneal closure has been used to relieve an abdominal hernia, but its indications have not been clearly defined. As a result, a high rate of complications has been reported in the literature. The study of this technique, which is usually performed under conscious sedation and through small incisions, has shown that it can be a useful method of treating an incisional hernia.

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