Coronary Dilatation Catheter for Heart Disease
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: OrbusNeich
Must not be taking: Aspirin, Heparin, Anti-platelets, others
Disqualifiers: Acute MI, Pregnancy, CVA, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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).12345
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.678910
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).3581112
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 am 18 years old or older.
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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.
See 14 more
Trial 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 (Balloon Catheter)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Sapphire 3 Coronary Dilatation CatheterExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University Hospital MidtownAtlanta, GA
Piedmont Heart InstituteAtlanta, GA
Emory University HospitalAtlanta, GA
Emory St. Joseph's HospitalAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
OrbusNeichLead Sponsor
AvaniaIndustry Sponsor
References
Improvement of cardiorespiratory function after percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. [2019]The objective of this study was to investigate the effect of a 3-mo training program for patients with either a percutaneous transluminal coronary angioplasty (PTCA) or a coronary artery bypass grafting (CABG).
Percutaneous transluminal coronary angioplasty. [2016]Percutaneous transluminal coronary angioplasty (PTCA) has revolutionized the treatment of patients with coronary disease. As many as 25 per cent of those requiring myocardial revascularization can now undergo PTCA instead of bypass surgery. This article reviews PTCA techniques, clinical results, case selection, complications, recent advances in equipment design, restenosis rate, use in acute myocardial infarction, and PTCA of coronary bypass grafts.
Nonsurgical myocardial revascularization: initial experience with percutaneous transluminal coronary angioplasty. [2004]Coronary artery atheromata obstruct coronary blood flow and produce myocardial ischemia. Percutaneous transluminal coronary angioplasty (PTCA) was performed to dilate narrowed coronary arteries on 16 occasions in 15 patients with severe proximal coronary artery narrowings and significant clinical angina pectoris. The lesions involved the left-anterior descending (LAD) coronary artery in nine patients (10 dilatation procedures), the right coronary artery (RCA) in five, and the circumflex coronary artery in one. Successful dilatation was achieved on nine occasions (56%): in 7 of the 10 LAD lesions (70%), in 2 of the 5 RCA lesions (40%), but not in the patient with circumflex disease. Successful dilatation was accompanied by a significant improvement in symptoms and in myocardial performance, as judged by atrial pacing MUGA (multigated) ventriculography. The ischemic response of the ventricle to stress the significantly reduced or abolished. PTCA is a useful, nonoperative method for dilating obstructed coronary arteries and for improving myocardial blood flow.
[Percutaneous transluminal coronary angioplasty in ischemic heart disease]. [2010]Percutaneous transluminal coronary angioplasty (PTCA) is a transarterial catheterization technique for dilatation of coronary artery stenoses. Together with coronary artery bypass grafting (CABG) the method forms the basis for the invasive revascularization, both in the case of stable and unstable angina pectoris as well as an acute myocardial infarction (AMI), where thrombolytic therapy is contraindicated. The main indications are primarily patients with few and/or short coronary artery stenoses, whereas CABG is primarily performed in other situations and always in case of left main coronary stenoses. The primary success rate is 85-95% with clinical recurrence and cardiac events in 15-30% of patients with one-vessel disease and 25-50% with multi-vessel disease. Early recurrence is mainly due to restenosis, while late (> 8 months) is mostly caused by new-developed stenoses. The complications are few; acute occlusion at the site of dilatation occurs in 5-10%, leading to acute CABG in approximately 3% and non-fatal AMI in 2%. Mortality is less than 1%. Taking differences in the patient populations related to indications into account, the results of PTCA equal those of CABG as regards recurrence of anginal pain, AMI and mortality and are superior to antianginal medical treatment.
Clinical experience with the ACS RX Lifestream coronary dilatation catheter: a new low profile perfusion balloon catheter. [2016]Although the use of the perfusion balloon catheter (PBC) has been widely accepted, there are some indicational limitations in percutaneous transluminal coronary angioplasty (PTCA). A new low profile perfusion balloon catheter, the ACS RX Lifestream Coronary Dilatation Catheter, was developed by Advanced Cardiovascular Systems, Inc. in which material and structures were improved to reduce previous limitations. PURPOSE AND STUDY DESIGN: In order to evaluate the ACS RX Lifestream Catheter's performance not only in PTCA but also in stent implantation, we used the catheter in 45 consecutive patients (male = 35, mean age 66 years) with combined use of 6F guiding catheter. Exclusions included total occlusions, long diffuse and acute MI lesions. There were 4 with Left Main Trunk Disease (LMTD), 15 with single vessel disease, 26 with multi-vessel disease, 20 with prior MI, 4 with prior CABG, and 10 with unstable angina. In bare stent procedures, a Johnson & Johnson metal stent was mounted on an ACS RX Lifestream Catheter previously used for predilation. Stent delivery and post-dilatation were performed using the same balloon.
[Interventional therapy of bypass stenoses]. [2016]Percutaneous balloon angioplasty (PTCA) of lesions in aorto-coronary saphenous vein grafts remains one of the most hazardous procedures in interventional cardiology. It is associated with a high rate of distal embolizations, increased incidence of periprocedural myocardial infarctions and amplified in-hospital and long-term mortality. Moreover, PTCA is complicated by a high rate of restenosis, which did not decline significantly after the implantation of coronary stents.
Cardiovascular devices; reclassification of certain percutaneous transluminal coronary angioplasty (PTCA) catheters. Final rule. [2010]The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' that will serve as the special control for the reclassified device type.
[Percutaneous transluminal coronary angioplasty and directional coronary atherectomy: a short review of recent progress]. [2010]Since the invention of Gruentzig AR in 1977, percutaneous transluminal coronary angioplasty (PTCA) has become a widely accepted therapeutic measure for the treatment of patients with ischemic heart disease (IHD), as well as coronary artery bypass grafting (CABG). The rate of initial success in PTCA elevated up to more than 90% recently, in accordance with the progress in technology and the operator's skill. The limitations of PTCA are acute coronary occlusion which occurs in a few percent during or just after the procedure, and restenosis which occurs in thirty to fourty percent within six months. Some new devices have been invented to add better results for the patients. Directional coronary atherectomy (DCA) is one of the devices to remove atheroma in narrow segment, instead of splitting it. DCA can create a larger and smoother lumen than that created with PTCA, and it may be expected to reduce the restenosis rate. The therapeutic choice in IHD is still controversial. At present, several clinical trials are being conducted in order to evaluate and compare medical therapy, CABG, and PTCA. These results will provide informations to help the decision making in the management of the patients with IHD.
Operative procedures not involving the heart after percutaneous transluminal coronary angioplasty. [2010]The benefit of coronary artery bypass grafting (CABG) in patients with coronary artery disease (CAD) who require extensive surgical procedures not involving the heart has been established. During the past decade, percutaneous transluminal coronary angioplasty (PTCA) has been developed as an alternative therapy to CABG for patients with CAD. In an attempt to determine the safety of other surgical procedures after PTCA, we retrospectively reviewed 148 patients who underwent 193 surgical procedures from four to 1,867 days after PTCA for CAD. Seventy-two patients had surgical treatment within 90 days of PTCA. Thirty-five patients had CABG prior to PTCA, and 113 had PTCA as the initial treatment for CAD. Four patients died postoperatively, only one death was cardiac in origin. One patient had a myocardial infarction postoperatively (the one cardiac death). Fifteen patients had other cardiac complications (nine patients with arrhythmias and six with myocardial ischemia). Patients operated upon within 90 days of PTCA had no increased cardiac morbidity, although the one myocardial infarction occurred in this group. No difference in cardiac morbidity occurred in patients with multivessel CAD treated by PTCA compared with single vessel disease. However, patients more than 60 years of age had more cardiac problems (16 of 110) than those less than 60 years of age (zero of 38) (p = 0.01). Treatment of CAD by PTCA protects the myocardium from fatal cardiac events and myocardial infarction during subsequent noncardiac operative procedures even early (less than 90 days) in the post-PTCA period. Older patients seem to be at higher risk, however, for nonfatal cardiac complications.
Percutaneous transluminal coronary angioplasty: current status and future trends. [2019]Although originally percutaneous transluminal coronary angioplasty (PTCA) was used only in patients with well-preserved left ventricular function and single-vessel coronary disease, the criteria for selection of patients have enlarged as experience with the procedure has accumulated. Currently, patients with multivessel coronary disease, coronary occlusions, or myocardial infarction are also eligible to undergo PTCA. Technologic advances such as steerable guidewire systems have improved the success rates and have facilitated dilation of severe lesions even in tortuous vessels. Despite the increasing complexity of cases, the frequency of occurrence of complications (such as coronary dissection, occlusion, and infarction) has decreased while the success rates have improved substantially.
[Gradual coronary dilatation using double balloon catheters]. [2012]For the purpose of coronary angioplasty (PTCA) coronary stenoses over 80% usually can only be passed with very small catheters. We therefore developed an instrument with a very small tip-diameter and two balloons of different diameters arranged in line. In 9 cases primary success has been achieved and the degree of stenoses reduced from 89% to 22%. The gradient of 58 mm Hg was only 11 mm Hg after PTCA. When used with caution, the advantages of this catheter in high-degree coronary stenoses is obvious.
[Percutaneous transluminal dilation by catheter of coronary - artery stenosis (author's transl)]. [2006]Since September 1977 until July 1979, 82 patients with various coronary lesions have undergone percutaneous transluminal coronary angioplasty (PTCA). By this technic, a catheter system is introduced through a systemic artery under local anesthesia to dilate a stenotic artery by controlled inflation. In 60 patients (73%) anatomical and hemodynamic success could be noted, which led to improvement in clinical parameters e.g. reduction of coronary narrowing of the transluminal diameter from a mean of 82 +/- 11% to 34 +/- 16% (p less than 0.001) and reduction of trans-stenotic coronary gradient from 56 +/- 15 to 19 +/- 12 mmHg (p less than 0.001). Nine patients, three of whom had signs of transmural myocardial infarction on the ECG had undergone emergency surgery for a coronary by-pass, this been due to the deterioration of clinical condition after the attempt to carry out coronary angioplasty. 42 out of 60 treated patients had at least one late control. 33 showed an improvement in cardiac efficiency campared with the pre-dilatation period. Patients with uncalcified single-vessel stenosis, less than 1 cm in length and a short history of pain appear to be most suitable for the procedure. More cases and follow-up datas are necessary to evaluate the efficiency of this new technic as compared with current medical and surgical treatments of ischemic heart disease.