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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the VasoStar guidewire, a tool designed to help doctors treat difficult-to-reach blockages in the heart's arteries. The goal is to improve the speed and effectiveness of crossing these blockages, potentially leading to better treatment outcomes for patients. The trial seeks individuals with a complete blockage in a heart artery that standard methods have not resolved and who are suitable candidates for a non-emergency heart procedure. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could enhance future heart treatments.

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 prior data suggests that the VasoStar guidewire system is safe for crossing vascular occlusion lesions?

Research has shown that guidewire systems, such as the VasoStar, have become safer over time due to improved design and more skilled operators. Earlier studies tested the VasoStar guidewire system for its ability to navigate complex heart blockages. These studies are crucial for ensuring the guidewire's safe use.

Although specific safety details for VasoStar aren't fully outlined in these sources, its continued study suggests it has demonstrated some safety and potential benefit. Prospective trial participants should consult their doctor to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VasoStar guidewire system is unique because it is designed to effectively cross vascular occlusion lesions in cases of heart blockages. Unlike traditional methods like balloon angioplasty or stenting, which mechanically open blocked arteries, VasoStar provides a more precise approach by using a guidewire system specifically engineered to navigate through difficult blockages. This could potentially lead to safer procedures with fewer complications and quicker recovery times. Researchers are excited about VasoStar because it promises to enhance the precision and safety of procedures aimed at clearing heart blockages, potentially transforming the standard approach to coronary artery disease treatment.

What evidence suggests that the VasoStar guidewire system is effective for crossing vascular occlusion lesions?

Research has shown that the VasoStar guidewire system, used by participants in this trial, is designed to improve the success rate of opening heart blockages. Studies indicate that this guidewire can help clear tough blockages and restore blood flow in the heart. The VasoStar uses vibrations to break through hardened plaque known as chronic total occlusions (CTOs), which are stubborn blockages in the arteries. Early findings suggest that this technology could simplify the placement of stents, small tubes that keep arteries open. This method may offer a more efficient way to treat heart blockages compared to traditional guidewires. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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 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]

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 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 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]

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]

Citations

1. withpower.com withpower.com/trial/phase-chronic-angina-2-2024-995e7

VasoStar Guidewire for Heart Blockages (VST100 Trial) What data supports the effectiveness of the VasoStar Vibrational Guidewire System treatment for heart blockages? The use of guidewires in heart procedures ...

2. ctv.veeva.com ctv.veeva.com/study/vasostar-vibrational-guidewire-system-to-facilitate-crossing-coronary-artery-chronic-total-occlusion

VasoStar Vibrational Guidewire System to Facilitate Crossing ... The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

3. app.trialscreen.org app.trialscreen.org/trials/vasostar-vibrational-guidewire-system-to-facilitate-crossing-coronary-trial-nct06193954

VasoStar Vibrational Guidewire System to Facilitate ... If successful, this new guidewire system could improve the chances of successfully opening these blockages and restoring blood flow to the heart muscle. Risks:.

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06193954

VasoStar guidewire system in Chronic Total Occlusion of ... The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

5. medcitynews.com medcitynews.com/2011/08/vasostars-vibrating-guidewire-takes-aim-at-coronary-artery-blockages/

VasoStar aims to cut through heart blockages VasoStar's technology is designed to break through plaque formations called chronic total occlusions (CTOs) to place stents. About 10 percent of ...

6. trialx.com trialx.com/clinical-trials/listings/319318/vasostar-vibrational-guidewire-system-to-facilitate-crossing-coronary-artery-chronic-total-occlusions/

Chronic Total Occlusion of Coronary Artery ... This Early Feasibility Study (EFS) is proposed to evaluate the initial safety and efficacy of the VasoStar guidewire system to cross complex ...

7. clinconnect.io clinconnect.io/trials/NCT06193954

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