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Coronary Artery DiseaseCTO-PCINCT02379923

The Asahi Intecc PTCA Chronic Total Occlusion Study

A study testing Crossing of Coronary Artery CTO in people with Coronary Artery Disease and Coronary Artery Chronic Total Occlusion, run by Asahi Intecc USA Inc at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Crossing of Coronary Artery CTO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
12 sitesUnited States
Study dates
Jun 2015to Jan 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • Subject is ≥ 18 years of age at the time of consent
  • Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
  • Subject is eligible and consents to undergo PCI procedure
  • Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)
  • Subject is willing and able to sign an Informed Consent Form approved by a local Institutional Review Board
Show all 9Show fewer
  • Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure
  • Angiographic Inclusion Criteria:
  • A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. Non-study lesions will be treated first. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the angiographic characteristics consistent with high-grade native coronary stenosis (TIMI 0) and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram. An attempt to cross the target lesion with at least one Asahi guidewire or a Corsair microcatheter must be made.

Who cannot join

  • General Exclusion Criteria:
  • Subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically
  • Evidence of acute Myocardial Infarction (MI) within 72 hours of the intended treatment defined as cardiac enzymes greater than Upper Limit of Normal (ULN).
  • Previous coronary interventional procedure of any kind within the 30 days prior to the procedure
  • Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin, etc.)
  • Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement
Show all 32Show fewer
  • Subjects with known history of clinically significant abnormal laboratory findings including:
  • Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks
  • Thrombocytopenia (<100,000 platelets/mm3)
  • AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN
  • Serum creatinine > 2.0 mg/dL
  • Subjects with evidence of ongoing or active clinical instability including the following:
  • Sustained systolic blood pressure < 100 mmHg or cardiogenic shock
  • Acute pulmonary edema or severe congestive heart failure
  • Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
  • Suspected dissecting aortic aneurysm
  • Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
  • History of stroke or transient ischemic attack within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  • Subjects with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study
  • Known previous medical condition yielding expected survival less than 1 year
  • Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
  • Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
  • Angiographic Exclusion Criteria:
  • Occlusion involves segment within previous stent
  • Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
  • Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
  • It has been at least 9 months since the previous stenting
  • That target lesion is at least 15 mm away from the previously placed stent
  • The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis, based on visual estimate
  • The target vessel has other lesions proximal to the total occlusion identified with greater than 75% diameter stenosis based on visual estimate. However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (i.e., tandem lesions) are acceptable.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Mount Sinai Hospital

    New York, New York, 00029

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • Advocate Health and Hospitals Corp.

    Oakbrook Terrace, Illinois, 60181

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • University of Washington

    Seattle, Washington, 98195

  • PeaceHealth Sacred Heart Medical Center

    Springfield, Oregon, 97477

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

Procedure success will be defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE).

Read the detailed description

This prospective, multi-center, single-arm, intent-to-treat (ITT) study is designed to assess the safety and effectiveness of the investigational products for the treatment of CTOs in a native coronary artery.

The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the CTO in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

The population for this study is subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a CTO in a native coronary artery, who are suitable for a percutaneous revascularization.

Procedure success will be defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital major adverse cardiac events (MACE). All subjects are followed through hospital discharge.

Being tested
Crossing of Coronary Artery CTO
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crossing of Coronary Artery CTODevice

    Also called Corsair, Gaia, Asahi Guide Wires

    Standard angiographic procedures will be followed for this study. The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.

    Procedure success will be defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital MACE.

    Other Name: ASAHI Corsair Microcatheter, ASAHI PTCA Guide Wires

Study groups in NCT02379923
Study groupRoleWhat they receive
Crossing of Coronary Artery CTOExperimentalThis is a single arm intent to treat study. A subject is considered enrolled when the subject has given informed consent and meets all inclusion and exclusion criteria, including angiographic inclusion and exclusion criteria, which includes an attempt to cross the target lesion with an investigational device (ASAHI PTCA Guidewire or ASAHI Corsair Microcatheter). Clinical evaluation up to hospital discharge is conducted on all enrolled subjects. The purpose of the clinical follow-up is to determine if the subject has experienced or is experiencing any adverse events
Receives: Device: Crossing of Coronary Artery CTO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure Success

    Angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital MACE.

    Measured: Through hospital discharge, typically 24 hours post procedure

Secondary outcomes (8)

  1. Frequency of Successful Recanalization

    Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.

    Measured: During Procedure

  2. Frequency of In-hospital MACE

    Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.

    Measured: Up to hospital discharge

  3. Frequency of Perforation

    Frequency of perforation during the procedure.

    Measured: During Procedure

  4. Frequency of Dissection

    Frequency of dissection reported during the procedure

    Measured: During procedure

  5. Mean Procedural Time

    The length of the procedure (The first successful insertion of the guide catheter at an arteriotomy site is considered the start of the procedure. A procedure is considered complete once the guide catheter is removed from the arteriotomy site.)

    Measured: During Procedure

  6. Mean Contrast Volume

    Volume of contrast administered during procedure

    Measured: During Procedure

  7. Mean Absorbed Radiation Dose in mGy

    Absorbed radiation dose in mGy during procedure

    Measured: During Procedure

  8. Procedural Success (Evaluated According to Crossing Technique)

    The percentage of subjects with procedure success according to crossing technique

    Measured: Through hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379923
Sponsor's protocol ID
AIUCT-001
Acronym
CTO-PCI
Status last verified
Jun 2018
First submitted
23 Feb 2015
Last updated
18 Jul 2018
Data monitoring committee
Yes

Publications

  • Park CS, Kim HY, Park HJ, Ihm SH, Kim DB, Lee JM, Kim PJ, Park CS, Moon KW, Yoo KD, Jeon DS, Chung WS, Seung KB, Kim JH. Clinical, electrocardiographic, and procedural characteristics of patients with coronary chronic total occlusions. Korean Circ J. 2009 Mar;39(3):111-5. doi: 10.4070/kcj.2009.39.3.111. Epub 2009 Mar 25.

    PubMed 19949597

  • Oesterle SN, Bittl JA, Leon MB, Hamburger J, Tcheng JE, Litvack F, Margolis J, Gilmore P, Madsen R, Holmes D, Moses J, Cohen H, King S 3rd, Brinker J, Hale T, Geraci DJ, Kerker WJ, Popma J. Laser wire for crossing chronic total occlusions: "learning phase" results from the U.S. TOTAL trial. Total Occlusion Trial With Angioplasty by Using a Laser Wire. Cathet Cardiovasc Diagn. 1998 Jun;44(2):235-43. doi: 10.1002/(sici)1097-0304(199806)44:23.0.co;2-k.

    PubMed 9637452

  • Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.

    PubMed 8362709

  • Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.

    PubMed 15842978

  • Sirnes PA, Golf S, Myreng Y, Molstad P, Emanuelsson H, Albertsson P, Brekke M, Mangschau A, Endresen K, Kjekshus J. Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol. 1996 Nov 15;28(6):1444-51. doi: 10.1016/s0735-1097(96)00349-x.

    PubMed 8917256

  • Moussa I, Di Mario C, Moses J, Reimers B, Di Francesco L, Blengino S, Colombo A. Comparison of angiographic and clinical outcomes of coronary stenting of chronic total occlusions versus subtotal occlusions. Am J Cardiol. 1998 Jan 1;81(1):1-6. doi: 10.1016/s0002-9149(97)00859-x.

    PubMed 9462596

  • Sirnes PA, Golf S, Myreng Y, Molstad P, Albertsson P, Mangschau A, Endresen K, Kjekshus J. Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study. J Am Coll Cardiol. 1998 Aug;32(2):305-10. doi: 10.1016/s0735-1097(98)00247-2.

    PubMed 9708454

  • Surmely JF, Tsuchikane E, Katoh O, Nishida Y, Nakayama M, Nakamura S, Oida A, Hattori E, Suzuki T. New concept for CTO recanalization using controlled antegrade and retrograde subintimal tracking: the CART technique. J Invasive Cardiol. 2006 Jul;18(7):334-8.

    PubMed 16816442

  • Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14. doi: 10.1016/s0735-1097(01)01349-3.

    PubMed 11499731

  • Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8. doi: 10.1016/s0735-1097(03)00312-7.

    PubMed 12767645

  • Prasad A, Rihal CS, Lennon RJ, Wiste HJ, Singh M, Holmes DR Jr. Trends in outcomes after percutaneous coronary intervention for chronic total occlusions: a 25-year experience from the Mayo Clinic. J Am Coll Cardiol. 2007 Apr 17;49(15):1611-1618. doi: 10.1016/j.jacc.2006.12.040. Epub 2007 Apr 2.

    PubMed 17433951

  • Valenti R, Migliorini A, Signorini U, Vergara R, Parodi G, Carrabba N, Cerisano G, Antoniucci D. Impact of complete revascularization with percutaneous coronary intervention on survival in patients with at least one chronic total occlusion. Eur Heart J. 2008 Oct;29(19):2336-42. doi: 10.1093/eurheartj/ehn357. Epub 2008 Aug 5.

    PubMed 18682446

Questions about this trial

What is this clinical trial studying?

A study testing Crossing of Coronary Artery CTO in people with Coronary Artery Disease and Coronary Artery Chronic Total Occlusion, run by Asahi Intecc USA Inc at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success (time frame: Through hospital discharge, typically 24 hours post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379923, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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