VasoStar Guidewire for Heart Blockages

(VST100 Trial)

Recruiting at 1 trial location

Overseen By Mihaela Plesa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VasoStar, LLC

Disqualifiers: Pregnancy, Congestive heart failure, Hypertension, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

10 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the VasoStar Vibrational Guidewire System treatment for heart blockages?

The use of guidewires in heart procedures, like the VasoStar, is supported by research showing that guidewires can help monitor blood flow and detect complications during coronary interventions, which are procedures to open blocked heart arteries. ^{1 2 3 4 5}

Is the VasoStar Guidewire safe for use in humans?

The safety profile of guidewire systems, like the GuideLiner, has improved over time with better design and more experienced operators. However, complications such as guidewire-induced coronary spasm, which can be serious, have been reported, highlighting the importance of careful use and management. ^{1 6 7 8 9}

How is the VasoStar Guidewire treatment different from other treatments for heart blockages?

The VasoStar Guidewire treatment is unique because it uses a vibrational guidewire system that generates complex vibratory movements to help navigate and cross blocked heart vessels, which is different from conventional methods that rely on static guidewires. ^{4 10 11 12 13}

What is the purpose of this trial?

The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

Eligibility Criteria

This trial is for adults over 18 with chronic angina or total blockage in a coronary artery that's lasted more than 3 months and hasn't been cleared by standard treatments. They must have a left ventricle ejection fraction over 20% and be able to follow the study rules. People can't join if they're pregnant, prisoners, have severe heart failure, recent heart attack, uncontrolled high blood pressure, bad reactions to contrast media, certain brain vessel diseases or are in another study.

Inclusion Criteria

Voluntarily sign a Patient Informed Consent Form specific to the study

I am a good candidate for a planned procedure to open narrowed arteries in my heart.

I have a completely blocked artery in my heart that hasn't improved with standard treatment.

Exclusion Criteria

Pregnancy

Extensive dissection created by refractory guidewire

I have not had a heart attack in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the VasoStar guidewire system to cross vascular occlusion lesions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• VasoStar

Trial Overview The VasoStar guidewire system is being tested to see if it can better help clear out completely blocked arteries in the heart that haven't responded to usual treatment methods. The aim is to make it easier and quicker for doctors to get through these tough blockages during angioplasty procedures.

Participant Groups

Group I: VasoStar guidewire system Experimental Treatment 1 Intervention

The VasoStar guidewire system will be used to cross vascular occlusion lesions.

Who Is Running the Clinical Trial?

VasoStar, LLC

Lead Sponsor

Trials

1

Recruited

10+

Summa Health

Collaborator

Trials

2

Recruited

50+

Findings from Research

In a study of 303 patients undergoing transcatheter aortic valve replacement (TAVR), left ventricular (LV) stimulation significantly reduced procedure duration compared to right ventricular (RV) stimulation, with mean times of 48.4 minutes versus 55.6 minutes, respectively.

Both LV and RV stimulation showed similar efficacy and safety outcomes, with procedural success rates of 100% for LV and 99.3% for RV, indicating that LV stimulation is a safe and effective alternative that also lowers costs and fluoroscopy time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. Faurie, B., Souteyrand, G., Staat, P., et al.[2020]

The EDEN tool effectively indicates the radial depth of guidewires during intramyocardial navigation, achieving 97% accuracy in classifying positions within the heart muscle based on electrogram signatures from 53 swine procedures.

This technique allows for new transcatheter procedures, such as MIRTH ventriculoplasty, enhancing the ability to perform complex heart interventions safely and accurately by combining EDEN with traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EDEN (Electrocardiographic Radial Depth Navigation): A Novel Approach to Navigate Inside Heart Muscle. Bruce, CG., Yildirim, DK., Kolandaivelu, A., et al.[2023]

The HeartSpan Steerable Sheath (HSS) was successfully used in 15 patients for endovascular treatment of complex vascular issues, achieving successful cannulation and stenting in 21 out of 23 target vessels, demonstrating its efficacy in challenging cases.

The HSS allowed for successful deployment of fenestrated grafts and other complex procedures, with no stent dislocations and maintained patency of aortic branches one year post-procedure, highlighting its safety and potential as a valuable tool in vascular surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of steerable sheaths for complex aortic procedures. Harrison, B., Bond, R.[2023]

The 'parallel anchor sheath snare' technique provides a novel and effective method for advancing delivery systems during percutaneous pulmonary valve implantation, especially in patients with challenging right ventricular outflow tracts.

In two reported cases, this technique successfully supported the delivery of a stent-valve, resulting in excellent valve function and good patient condition after 8 months of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing a Bulky Delivery System Using a Novel Technique During Percutaneous Pulmonary Valve Implantation. Pan, W., Hou, S., Chen, S., et al.[2022]

Ultrasound transducer-tipped guidewires are effective tools for monitoring coronary flow during interventions, providing real-time insights into the quality of the procedure's outcome.

By analyzing flow patterns and average velocity trends post-procedure, these guidewires can help predict potential complications, such as abrupt closure or the recurrence of problematic plaques, enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery flow monitoring: the value of intravascular Doppler for detection of complications after interventions. Anderson, HV., Kirkeeide, RL., Willerson, JT., et al.[2019]

The GuideLiner catheter is designed to assist in complex coronary interventions by providing additional support for equipment delivery, particularly in challenging anatomical situations.

A previously unreported complication involving the dislodgment of the GuideLiner's distal cylinder into the aortic root was successfully managed percutaneously, demonstrating the safety and effectiveness of this novel removal approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A unique complication with use of the GuideLiner catheter in percutaneous coronary interventions and its successful management. Bhat, T., Baydoun, H., Tamburino, F.[2016]

In a study involving 165 patients with sick sinus syndrome or AV block, the total complication rate for atrial lead implantation was 20.6%, with issues like electrode displacement and sensing disturbances being the most common.

Despite the complications, most were not dangerous and could be easily treated, suggesting that the use of atrial leads for physiological pacing should not be discouraged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications associated with use of atrial electrodes]. Swiatecka, G., Sielski, S., Wilczek, R., et al.[2006]

The GuideLiner catheter system enhances the success rate of complex percutaneous coronary interventions, making it a valuable tool for cardiologists.

With each new generation of the GuideLiner and as operators gain more experience, the safety profile of the device has improved, indicating its reliability in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A helping hand: GuideLiner use to facilitate stent delivery. Brown, BJ., Abbott, JD.[2018]

Guidewire-induced coronary spasm can be life-threatening, highlighting the need for careful monitoring during procedures involving guidewires.

Immediate recognition of the spasm and the administration of coronary vasodilators are crucial for effective management, as balloon dilation may exacerbate the spasm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Vessel Closure in Rescue Percutaneous Coronary Intervention. Ahmed, AS., Agarwal, T.[2021]

The Szabo (anchor-wire) technique and its modifications were successfully used in six patients with congenital heart lesions, allowing for precise stent positioning in complex cases such as maintaining ductus arteriosus permeability and creating fenestrations in the interatrial septum.

This technique offers improved accuracy over traditional methods for stent implantation, but it requires careful training and awareness of potential complications, highlighting the importance of a learning curve for medical professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Szabo (anchor-wire) technique concept for stent implantation in congenital heart lesions. Girona, J., Martí, G., Betrian, P., et al.[2021]

In a study of 106 patients undergoing biventricular device implantation, temporary right ventricular pacing using a 0.035'' guidewire was successfully achieved in all cases, demonstrating its reliability as a backup method.

This technique proved to be safe, with no arrhythmias observed during testing, and effectively provided pacing for two patients who developed complete heart block during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Backup right ventricular pacing with a 0.035'' guidewire during implantation of left ventricular leads. Burri, H., Sunthorn, H., Zimmermann, M., et al.[2009]

The activated guidewire technique successfully enabled coronary angioplasty in 33 out of 47 patients who previously experienced failed conventional angioplasty, demonstrating its efficacy in treating chronic coronary artery occlusions.

This innovative method, which uses a motorized device to create vibratory movements in the guidewire, was particularly effective for stump-like occlusions, comprising 80% of the cases, and can be applied at any point during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activated-guidewire technique for treating chronic coronary artery occlusion. Rees, MR., Michalis, LK.[2019]

The newly developed 6.5-Fr sheathless guiding catheter, referred to as a virtual 4.5-Fr system, offers a comparable outer diameter to a conventional 4.5-Fr introducer sheath while maintaining a larger inner diameter, allowing for effective treatment of renal artery stenosis.

This innovative catheter design may reduce vascular access complications and improve patient outcomes, as demonstrated in a successful case treated via the transradial route.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal artery intervention using a virtual 4.5-Fr guiding catheter. Takeshita, S., Matsumi, J., Saito, S.[2016]

References

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

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. [2020]

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

EDEN (Electrocardiographic Radial Depth Navigation): A Novel Approach to Navigate Inside Heart Muscle. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Use of steerable sheaths for complex aortic procedures. [2023]

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

Advancing a Bulky Delivery System Using a Novel Technique During Percutaneous Pulmonary Valve Implantation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Coronary artery flow monitoring: the value of intravascular Doppler for detection of complications after interventions. [2019]

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

A unique complication with use of the GuideLiner catheter in percutaneous coronary interventions and its successful management. [2016]

7. Poland pubmed.ncbi.nlm.nih.gov

[Complications associated with use of atrial electrodes]. [2006]

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

A helping hand: GuideLiner use to facilitate stent delivery. [2018]

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

Acute Vessel Closure in Rescue Percutaneous Coronary Intervention. [2021]

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

Extended Szabo (anchor-wire) technique concept for stent implantation in congenital heart lesions. [2021]

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

Backup right ventricular pacing with a 0.035'' guidewire during implantation of left ventricular leads. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Activated-guidewire technique for treating chronic coronary artery occlusion. [2019]

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

Renal artery intervention using a virtual 4.5-Fr guiding catheter. [2016]