PerQseal® Device for Percutaneous Vascular Closure

(PATCH Trial)

Recruiting at 17 trial locations

Overseen By Chris Martin, Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivasure Medical Limited

Must not be taking: Anticoagulants

Disqualifiers: Infection, Coagulopathy, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

149 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device called PerQseal, which helps close up the hole in the artery after certain heart procedures. It is aimed at patients who need a reliable way to stop bleeding after these procedures. The device works like a plug to seal the hole and prevent bleeding.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on long-term anticoagulants with an INR > 2 within 12 hours prior to the procedure, you may be excluded from the trial. It's best to discuss your specific medications with the trial team.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on long-term anticoagulants with an INR greater than 2 within 12 hours prior to the procedure, you may not be eligible to participate.

What data supports the idea that PerQseal® Device for Percutaneous Vascular Closure is an effective treatment?

The available research does not provide specific data on the effectiveness of the PerQseal® Device for Percutaneous Vascular Closure. Instead, it discusses complications and outcomes related to other vascular closure devices like Angio-Seal and Perclose. These studies highlight issues such as arterial blockages and the need for surgical intervention, suggesting that while these devices can be effective, they also carry risks. Without direct data on PerQseal®, it's difficult to compare its effectiveness to other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the PerQseal® Closure Device System treatment?

The research suggests that vascular closure devices, like the PerQseal® system, are widely used to quickly stop bleeding and allow patients to move around sooner after procedures. However, they can sometimes cause complications, similar to other closure methods, which may require additional treatment. ^{1 2 3 4 5}

What safety data exists for the PerQseal® Device for vascular closure?

The provided research does not contain specific safety data for the PerQseal® Device or its variants. The studies mentioned focus on other vascular closure devices like Solysafe, StarClose SE, and Perclose ProGlide™, discussing their safety and complications. To find safety data for the PerQseal® Device, one would need to look for studies or reports specifically evaluating this device. ^{6 7 8 9 10}

Is the PerQseal® Closure Device System a promising treatment?

Yes, the PerQseal® Closure Device System is a promising treatment because it offers a quick and effective way to close blood vessels after procedures, which can help patients recover faster and feel more comfortable. ^{2 4 9 11 12}

How is the PerQseal® Closure Device System treatment different from other vascular closure treatments?

The PerQseal® Closure Device System is unique because it offers a novel approach to closing vascular access sites percutaneously (through the skin) without the need for sutures, unlike other devices that may use suture-mediated closure, which can sometimes lead to complications like suture knot embolism. ^{2 4 9 11 12}

Research Team

William Gray, MD

Principal Investigator

Lankenau heart Institute

Sean Lyden, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults over 19 who need a catheter-based procedure like TAVR/TAVI, EVAR, TEVAR, or use of assist devices through the femoral artery. Women must not be pregnant or planning pregnancy during the study. Participants must consent to follow-up visits.

Inclusion Criteria

I am 19 years old or older.

Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements

I am not pregnant or breastfeeding and do not plan to become pregnant during the study.

Exclusion Criteria

Known type II heparin-induced thrombocytopenia

I had a minor procedure on my leg with a small tool and stitches or pressure for bleeding control within the last month.

I have a bleeding disorder or my blood doesn't clot properly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous catheter-based interventional procedures with the PerQseal vascular closure device to achieve haemostasis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including major and minor access site complications

30 days

1-2 visits (in-person)

Treatment Details

Interventions

• PerQseal® Closure Device System

Trial Overview The PerQseal vascular closure device system is being tested for its ability to safely and effectively close large openings in the femoral artery after procedures that require big sheaths (12-22 F size).

Participant Groups

Group I: Subjects implanted with PerQseal Vascular Closure Device Experimental Treatment 1 Intervention

Subjects implanted with bioabsorbable implant to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (up to 26 F arteriotomy) in patients undergoing percutaneous catheter-based interventional procedures.

PerQseal® Closure Device System is already approved in European Union, United States for the following indications:

Approved in European Union as PerQseal Closure Device System for:

• Percutaneous sealing of a common femoral arteriotomy in patients following interventional therapeutic endovascular procedures

Approved in United States as PerQseal Closure Device System for:

• Haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in subjects undergoing percutaneous catheter-based interventional procedures

Who Is Running the Clinical Trial?

Vivasure Medical Limited

Lead Sponsor

Trials

11

Recruited

700+

Findings from Research

In a review of 106 articles and five reported cases, thrombotic complications were observed following the use of the Angio-Seal percutaneous closure system, indicating potential risks associated with this method.

The rate of complications from percutaneous closure systems was found to be similar to that of traditional manual compression, but the complications from closure systems were often more complex and required surgical intervention, highlighting the need for vascular surgeons to be well-informed about these systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial thrombosis after using Angio-Seal. Georg, Y., Thaveau, F., Lejay, A., et al.[2016]

Vascular closure devices like Angio-Seal® are generally safe and effective for achieving quick hemostasis after angiographic procedures, allowing for early patient ambulation.

However, there is a rare risk of arterial injury leading to acute closure, which can be treated successfully with percutaneous methods such as the SilverHawk® plaque excision system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Angio-Seal® Vascular Closure Device-Induced Acute Femoral Artery Occlusion with SilverHawk® Directional Atherectomy. Sharma, R., Vamanan, K., Gupta, K.[2020]

In a study of 31 patients who underwent percutaneous closure with the Perclose device, 28 patients showed normal follow-up results, indicating that the device is generally safe and effective for closure procedures.

The study found that patients with normal femoral artery caliber and adequate platelet counts had minimal long-term complications, while those with preexisting atherosclerosis or severe thrombocytopenia experienced some issues, highlighting the importance of patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angiographic follow-up after suture-mediated femoral artery closure. Brown, DB., Crawford, ST., Norton, PL., et al.[2019]

Percutaneous closure devices, while increasingly popular for use after endovascular procedures, can lead to rare but serious complications such as arterial occlusion.

In this reported case, the arterial occlusion was caused by distal embolization of the suture material from the closure device, highlighting the potential risks associated with these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suture knot embolism--a rare complication of percutaneous arterial closure device. Lee, TL., Tseng, WK., Hsuang, CF., et al.[2010]

In a study of 894 patients undergoing arterial endovascular procedures, the use of vascular closure devices (VCDs) like Mynx, Perclose, and Angio-Seal showed a low rate of postoperative bleeding complications and device failures, indicating their safety for groin vessel closure.

Factors such as older age, undergoing interventional procedures, and having end-stage renal disease were identified as independent predictors of postoperative bleeding, highlighting the importance of patient characteristics in assessing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mynx Vascular Closure Device in Arterial Endovascular Procedures. Scott, MC., Spencer, HJ., Ali, AT., et al.[2022]

Percutaneous atrial septal defect (ASD) closure is generally considered a safe and effective procedure, with a low complication rate reported over the last decade.

However, this case highlights a rare but serious complication: a patient experienced cardiac tamponade 6 months post-closure due to a disarticulated Solysafe device and a broken wire that migrated into the pericardial space, leading to cardiac perforation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late cardiac perforation following percutaneous atrial septal defect closure using the Solysafe device. Cabrera, M., Contreras, A., Peirone, A.[2012]

The Mynx vascular-closure device was found to have a significantly higher risk of vascular complications compared to alternative devices, with a relative risk of 1.59 based on an analysis of 73,124 patients after PCI procedures.

Active surveillance of a national clinical registry effectively identified safety concerns within the first year, highlighting the importance of ongoing monitoring for medical devices to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registry-Based Prospective, Active Surveillance of Medical-Device Safety. Resnic, FS., Majithia, A., Marinac-Dabic, D., et al.[2022]

A review of the MAUDE database revealed 1,118 complications associated with the StarClose SE vascular closure device, with the most common issues being failure to achieve hemostasis (36.6%) and inability to complete the deployment sequence (24.0%).

The types and frequencies of complications reported in the MAUDE database significantly differ from those in clinical trials, suggesting that real-world usage may present additional challenges not captured in controlled studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database. Johnson, DT., Durack, JC., Fidelman, N., et al.[2013]

The Perclose ProGlide™ system is a safe and effective vascular closure device that has been shown to reduce complications associated with vascular access procedures compared to traditional methods like manual compression and surgical cut-down.

Studies indicate that using the Perclose ProGlide™ system can lead to quicker recovery times, including reduced time to deambulation and discharge, as well as decreased patient discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perclose Proglide™ for vascular closure. Del Prete, A., Della Rocca, DG., Calcagno, S., et al.[2021]

The Perclose suture-mediated closure device was successfully used in 95% of cases for arterial closure after angiography in 500 patients with lower extremity peripheral vascular disease, demonstrating its efficacy in this specific patient group.

While the overall major complication rate was low at 1.4%, the complications associated with the Perclose device were more severe than those typically seen with manual compression, indicating that careful patient selection and experience with the device are crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? Mackrell, PJ., Kalbaugh, CA., Langan, EM., et al.[2019]

The Angio-Seal device is commonly used for closing femoral arteries after catheterization, but there are rare cases of it dislocating and causing serious complications like distal embolization and limb ischemia.

In a unique case, a successful endovascular technique using Alligator Tooth Retrieval forceps was employed to manage a dislocated Angio-Seal, highlighting an effective emergency response to this rare complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular retrieval of a dislodged femoral arterial closure device with Alligator forceps. Boersma, D., van Strijen, MJ., Kloppenburg, GT., et al.[2016]

The VasoSeal vascular closure device has been used as the primary method for closing arteriotomy sites in approximately 2400 procedures since its adoption in mid-1998, indicating its widespread application and potential reliability in clinical practice.

This review highlights the technique of VasoSeal closure, suggesting that it may offer a practical alternative to traditional methods of managing puncture sites in interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial puncture closure using a collagen plug, II. (VasoSeal). Cleveland, G., Hill, S., Williams, S.[2004]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Arterial thrombosis after using Angio-Seal. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of Angio-Seal® Vascular Closure Device-Induced Acute Femoral Artery Occlusion with SilverHawk® Directional Atherectomy. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Angiographic follow-up after suture-mediated femoral artery closure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Suture knot embolism--a rare complication of percutaneous arterial closure device. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mynx Vascular Closure Device in Arterial Endovascular Procedures. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Late cardiac perforation following percutaneous atrial septal defect closure using the Solysafe device. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Registry-Based Prospective, Active Surveillance of Medical-Device Safety. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Perclose Proglide™ for vascular closure. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Endovascular retrieval of a dislodged femoral arterial closure device with Alligator forceps. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Arterial puncture closure using a collagen plug, II. (VasoSeal). [2004]