Clinical trial NCT02379923: The Asahi Intecc PTCA Chronic Total Occlusion Study
Official title: The Asahi Intecc PTCA Chronic Total Occlusion Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Chronic Total Occlusion
Lead sponsor: Asahi Intecc USA Inc
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2015-03-05
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* General Inclusion Criteria:

  1. Subject is ≥ 18 years of age at the time of consent
  2. 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
  3. Subject is eligible and consents to undergo PCI procedure
  4. Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG)
  5. Subject is willing and able to sign an Informed Consent Form approved by a local Institutional Review Board
  6. 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:
  7. 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.

Exclusion Criteria:

* General Exclusion Criteria:

  1. Subjects with any history of allergy to iodinated contrast that cannot be effectively managed medically
  2. Evidence of acute Myocardial Infarction (MI) within 72 hours of the intended treatment defined as cardiac enzymes greater than Upper Limit of Normal (ULN).
  3. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure
  4. 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.)
  5. Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement
  6. 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
  7. 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
  8. History of stroke or transient ischemic attack within the prior 6 months
  9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  10. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  11. 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
  12. Known previous medical condition yielding expected survival less than 1 year
  13. Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
  14. 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:
  15. Occlusion involves segment within previous stent
  16. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
  17. 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
  18. 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.

Primary outcomes:
measure: Procedure Success
timeFrame: Through hospital discharge, typically 24 hours post procedure
Secondary outcomes:
measure: Frequency of Successful Recanalization
timeFrame: During Procedure
measure: Frequency of In-hospital MACE
timeFrame: Up to hospital discharge
measure: Frequency of Perforation
timeFrame: During Procedure
measure: Frequency of Dissection
timeFrame: During procedure
measure: Mean Procedural Time
timeFrame: During Procedure
measure: Mean Contrast Volume
timeFrame: During Procedure
measure: Mean Absorbed Radiation Dose in mGy
timeFrame: During Procedure
measure: Procedural Success (Evaluated According to Crossing Technique)
timeFrame: Through hospital discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Oakbrook Terrace
country: United States
facility: Advocate Health and Hospitals Corp.
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Springfield
country: United States
facility: PeaceHealth Sacred Heart Medical Center
state: Oregon
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MidAmerica Heart Institute
name: Aaron Grantham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.