The Asahi Intecc PTCA Chronic Total Occlusion Study

NCT02379923 | Completed Results DMC

• 1 other identifier: AIUCT-001
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 12

Brief 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. 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).

Conditions

Coronary Artery Disease; Coronary Artery Chronic Total Occlusion

Outcome Measures

Primary Outcomes (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.

  Through hospital discharge, typically 24 hours post procedure

Secondary Outcomes (8)

• Frequency of Successful Recanalization

  During Procedure

• Frequency of In-hospital MACE

  Up to hospital discharge

• Frequency of Perforation

  During Procedure

• Frequency of Dissection

  During procedure

• Mean Procedural Time

  During Procedure

Study Arms (1)

Crossing of Coronary Artery CTO

EXPERIMENTAL

This 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

Device: Crossing of Coronary Artery CTO

Interventions

Crossing of Coronary Artery CTO DEVICE

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

Also known as: Corsair, Gaia, Asahi Guide Wires

Crossing of Coronary Artery CTO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before the study procedure
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asahi Intecc USA Inc: lead
• Medpace, Inc.: collaborator

Study Sites (12)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Advocate Health and Hospitals Corp.

Oakbrook Terrace, Illinois, 60181, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mount Sinai Hospital

New York, New York, 00029, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

PeaceHealth Sacred Heart Medical Center

Springfield, Oregon, 97477, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (12)

• 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.

  PMID: 19949597 BACKGROUND

• 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.

  PMID: 9637452 BACKGROUND

• 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.

  PMID: 8362709 RESULT

• 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.

  PMID: 15842978 RESULT

• 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.

  PMID: 8917256 RESULT

• 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.

  PMID: 9462596 RESULT

• 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.

  PMID: 9708454 RESULT

• 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.

  PMID: 16816442 RESULT

• 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.

  PMID: 11499731 RESULT

• 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.

  PMID: 12767645 RESULT

• 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.

  PMID: 17433951 RESULT

• 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.

  PMID: 18682446 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Robert Ricker
• Organization: Asahi Intecc USA, Inc.

robertr@asahi-intecc.com

408.429.3749

Study Officials

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

• Aaron Grantham, MD

  MidAmerica Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 5, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 18, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Locations

US (12)