The Asahi Intecc PTCA Chronic Total Occlusion Study

Coronary Artery Disease Clinical Trial

— CTO-PCI  

Official title:

The Asahi Intecc PTCA Chronic Total Occlusion Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379923
• Other study ID #: AIUCT-001
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2018
• Source: Asahi Intecc USA Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Chronic Total Occlusion
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Crossing of Coronary Artery CTO
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

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Dallas VA Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Advocate Health and Hospitals Corp.	Oakbrook Terrace	Illinois
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	University of Washington	Seattle	Washington
United States	PeaceHealth Sacred Heart Medical Center	Springfield	Oregon
United States	York Hospital	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Asahi Intecc USA Inc	Medpace, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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 chr — View 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. — View 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):1611-8. Epub 2007 Ap — View Citation

Sirnes PA, Golf S, Myreng Y, Mølstad 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 Cardio — View Citation

Sirnes PA, Golf S, Myreng Y, Mølstad 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 — View 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 — View 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 — View 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. 2 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of Successful Recanalization	Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.	During Procedure
Secondary	Frequency of In-hospital MACE	Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.	Up to hospital discharge
Secondary	Frequency of Perforation	Frequency of perforation during the procedure.	During Procedure
Secondary	Frequency of Dissection	Frequency of dissection reported during the procedure	During procedure
Secondary	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.)	During Procedure
Secondary	Mean Contrast Volume	Volume of contrast administered during procedure	During Procedure
Secondary	Mean Absorbed Radiation Dose in mGy	Absorbed radiation dose in mGy during procedure	During Procedure
Secondary	Procedural Success (Evaluated According to Crossing Technique)	The percentage of subjects with procedure success according to crossing technique	Through hospital discharge