Coronary Dilatation Catheter for Heart Disease

Recruiting at 14 trial locations

Overseen By Debbie Morrell, MSME

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OrbusNeich

Must not be taking: Aspirin, Heparin, Anti-platelets, others

Disqualifiers: Acute MI, Pregnancy, CVA, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Peri-procedural

170 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, or anti-platelet medications, you may not be eligible to participate.

What data supports the effectiveness of the Sapphire 3 Coronary Dilatation Catheter treatment for heart disease?

Research on similar treatments, like percutaneous transluminal coronary angioplasty (PTCA), shows that it can successfully widen narrowed coronary arteries, improving blood flow and reducing symptoms in many patients. The success rate for PTCA is high, with significant improvements in heart function and reduced symptoms of angina (chest pain). ^{1 2 3 4 5}

Is the Sapphire 3 Coronary Dilatation Catheter safe for use in humans?

The Sapphire 3 Coronary Dilatation Catheter, used in procedures like percutaneous transluminal coronary angioplasty (PTCA), has been associated with some risks such as restenosis (re-narrowing of the artery) and complications like coronary dissection and occlusion. However, advancements in technology have improved success rates and reduced complications over time, making it generally safer for use in humans. ^{6 7 8 9 10}

How does the Sapphire 3 Coronary Dilatation Catheter treatment differ from other treatments for heart disease?

The Sapphire 3 Coronary Dilatation Catheter is unique because it is a specialized balloon catheter used in percutaneous transluminal coronary angioplasty (PTCA) to dilate narrowed coronary arteries, improving blood flow to the heart. Unlike some other treatments, it offers a non-surgical option for patients with severe coronary artery narrowings, potentially reducing the need for more invasive procedures like coronary artery bypass grafting (CABG). ^{3 5 8 11 12}

What is the purpose of this trial?

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.

Research Team

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

Eligibility Criteria

This trial is for adults with certain heart conditions like chronic total occlusion and coronary artery disease. Participants must have one or two lesions in their arteries, be over 18, give written consent, not join other studies that conflict with this one during hospitalization, and are scheduled for a stent placement.

Inclusion Criteria

Subject or a legally authorized representative must provide written informed consent prior to any study related procedures

Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study

I have a blocked artery in my heart that has been present for at least 3 months.

Exclusion Criteria

My heart's artery spasms without major blockage.

I have had a heart procedure within the last 30 days.

My heart condition requires multiple stents due to a blockage at a branch point.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo percutaneous coronary intervention using the Sapphire 3 Coronary Dilatation Catheter to pre-dilate CTO lesions

Peri-procedural

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

24 hours post-procedure or until hospital discharge

Treatment Details

Interventions

• Sapphire 3 Coronary Dilatation Catheter

Trial Overview The Sapphire 3 Coronary Dilatation Catheter is being tested to see how safe it is and how well it works when used to open up blocked arteries in the heart before placing a stent. This study will observe patients after they undergo this procedure.

Participant Groups

Group I: Sapphire 3 Coronary Dilatation Catheter Experimental Treatment 1 Intervention

Single arm with investigational Sapphire 3 Coronary Dilatation Catheters

Sapphire 3 Coronary Dilatation Catheter is already approved in United States for the following indications:

Approved in United States as Sapphire 3 Coronary Dilatation Catheter for:

• balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion

Who Is Running the Clinical Trial?

OrbusNeich

Lead Sponsor

Trials

19

Recruited

11,800+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Findings from Research

A 3-month cardiac rehabilitation program significantly improved cardiorespiratory function in patients who underwent either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG), with both groups showing increased peak oxygen uptake (VO2peak).

Patients who had CABG demonstrated a greater percentage increase in VO2peak (32.8%) compared to those who had PTCA (14.6%), indicating that CABG patients had a higher training potential despite starting with lower fitness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of cardiorespiratory function after percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. Lan, C., Chen, SY., Hsu, CJ., et al.[2019]

Percutaneous transluminal coronary angioplasty (PTCA) has become a key treatment option for coronary disease, allowing up to 25% of patients needing myocardial revascularization to avoid more invasive bypass surgery.

The review covers various aspects of PTCA, including techniques, clinical outcomes, and recent advancements, highlighting its effectiveness and the importance of careful case selection to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transluminal coronary angioplasty. Levin, DC., Boxt, LM., Meyerovitz, MF.[2016]

In a study involving 15 patients with severe coronary artery narrowings, percutaneous transluminal coronary angioplasty (PTCA) successfully dilated narrowed arteries in 56% of cases, leading to significant symptom improvement and enhanced myocardial performance.

PTCA was particularly effective for lesions in the left-anterior descending artery, achieving a 70% success rate, and demonstrated its potential as a nonoperative method to improve blood flow to the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical myocardial revascularization: initial experience with percutaneous transluminal coronary angioplasty. Lewis, BS., Halon, DA., Weiss, AT., et al.[2004]

Percutaneous transluminal coronary angioplasty (PTCA) has a high primary success rate of 85-95% for treating coronary artery stenoses, making it an effective option for patients with few or short blockages.

While PTCA has low complication rates, with mortality less than 1%, it does have a risk of recurrence of cardiac events, particularly due to restenosis, affecting 15-30% of patients with one-vessel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal coronary angioplasty in ischemic heart disease]. Thayssen, P.[2010]

The ACS RX Lifestream Catheter was successfully used in 45 patients for both percutaneous transluminal coronary angioplasty (PTCA) and stent implantation, demonstrating its effectiveness across various lesion types without complications.

This catheter allows for the treatment of more complex lesions, as evidenced by a significant reduction in diameter stenosis from 81% pre-procedure to 12.8% post-procedure, indicating its potential to expand treatment options in coronary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with the ACS RX Lifestream coronary dilatation catheter: a new low profile perfusion balloon catheter. Saito, T., Yashita, S., Noda, K., et al.[2016]

Percutaneous balloon angioplasty (PTCA) in aorto-coronary saphenous vein grafts is highly risky, with significant rates of complications such as distal embolizations and myocardial infarctions, leading to increased mortality.

Recent advancements in stent designs, antiaggregatory treatments, and embolus protection devices show promise in improving the safety and effectiveness of PTCA procedures for these complex lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interventional therapy of bypass stenoses]. Baldus, S., Hamm, CW.[2016]

The FDA is reclassifying standard percutaneous transluminal coronary angioplasty (PTCA) catheters from class III to class II, which means they will now have less stringent premarket approval requirements.

Cutting/scoring PTCA catheters will remain in class III and still require premarket approval applications, ensuring that these specific devices continue to undergo rigorous evaluation before being marketed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular devices; reclassification of certain percutaneous transluminal coronary angioplasty (PTCA) catheters. Final rule. [2010]

Percutaneous transluminal coronary angioplasty (PTCA) has achieved an initial success rate of over 90% for treating ischemic heart disease, although it still faces challenges like acute coronary occlusion and a 30-40% restenosis rate within six months.

Directional coronary atherectomy (DCA) offers a promising alternative by removing atheroma to create a larger and smoother lumen, potentially reducing the restenosis rate compared to traditional PTCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal coronary angioplasty and directional coronary atherectomy: a short review of recent progress]. Abe, S., Handa, S.[2010]

Coronary artery disease (CAD) patients who underwent percutaneous transluminal coronary angioplasty (PTCA) experienced low rates of cardiac complications during subsequent non-cardiac surgeries, even when these surgeries occurred within 90 days after PTCA.

Older patients (over 60 years) showed a higher risk of nonfatal cardiac complications compared to younger patients, indicating that age may be a significant factor in postoperative cardiac safety after PTCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operative procedures not involving the heart after percutaneous transluminal coronary angioplasty. Allen, JR., Helling, TS., Hartzler, GO.[2010]

Percutaneous transluminal coronary angioplasty (PTCA) has expanded its eligibility criteria to include patients with more complex conditions, such as multivessel coronary disease and myocardial infarction, reflecting advancements in the procedure.

Technological improvements, like steerable guidewire systems, have led to higher success rates and fewer complications during PTCA, even in challenging cases with severe lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transluminal coronary angioplasty: current status and future trends. Holmes, DR., Vlietstra, RE.[2019]

A newly developed catheter with a very small tip diameter and two balloons was successfully used in 9 cases of severe coronary stenosis, reducing blockage from 89% to 22%.

The procedure significantly improved blood flow, as indicated by a reduction in pressure gradient from 58 mm Hg to 11 mm Hg after angioplasty, demonstrating the catheter's efficacy in treating high-degree coronary blockages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Gradual coronary dilatation using double balloon catheters]. Kappenberger, L., Steinbrunn, W., Tartini, R.[2012]

In a study of 82 patients undergoing percutaneous transluminal coronary angioplasty (PTCA), 73% achieved significant anatomical and hemodynamic success, with a notable reduction in coronary narrowing from 82% to 34% and a decrease in trans-stenotic gradient from 56 mmHg to 19 mmHg, indicating effective treatment of coronary lesions.

While PTCA showed promising results, 9 patients required emergency bypass surgery due to clinical deterioration, highlighting the need for careful patient selection, particularly favoring those with uncalcified, short stenoses and a brief history of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal dilation by catheter of coronary - artery stenosis (author's transl)]. Grüntzig, A., Maresta, A., Gossler, W., et al.[2006]

References

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

Improvement of cardiorespiratory function after percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. [2019]

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

Percutaneous transluminal coronary angioplasty. [2016]

3. Israel pubmed.ncbi.nlm.nih.gov

Nonsurgical myocardial revascularization: initial experience with percutaneous transluminal coronary angioplasty. [2004]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal coronary angioplasty in ischemic heart disease]. [2010]

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

Clinical experience with the ACS RX Lifestream coronary dilatation catheter: a new low profile perfusion balloon catheter. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

[Interventional therapy of bypass stenoses]. [2016]

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

Cardiovascular devices; reclassification of certain percutaneous transluminal coronary angioplasty (PTCA) catheters. Final rule. [2010]

8. Japan pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal coronary angioplasty and directional coronary atherectomy: a short review of recent progress]. [2010]

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

Operative procedures not involving the heart after percutaneous transluminal coronary angioplasty. [2010]

10. England pubmed.ncbi.nlm.nih.gov

Percutaneous transluminal coronary angioplasty: current status and future trends. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Gradual coronary dilatation using double balloon catheters]. [2012]

12. Italy pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal dilation by catheter of coronary - artery stenosis (author's transl)]. [2006]