A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

NCT01186198 | Completed Results FDA Device

• 1 other identifier: 10-802
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 4

Brief Summary

This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.

Conditions

Ischemic Heart Disease; Coronary Artery Stenosis; Chronic Coronary Total Occlusion; Coronary Bypass Graft Stenosis

Keywords

Coronary Dilatation Catheter; Balloon Dilatation Catheter; Angioplasty; Myocardial Ischemia; Coronary Stenosis; Percutaneous Coronary Intervention (PCI); Percutaneous Transluminal Coronary Angioplasty (PTCA); Chronic Total Occlusion (CTO)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Procedure Success

  Procedure success was defined as meeting all the following after single or multiple attempts: 1. Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion, 2. Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, 3. No vessel perforation, no flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon, and 4. Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.

  On Day 0 (From the start to end of the interventional procedure)

Secondary Outcomes (6)

• Rate of Device Success

  On Day 0 (From the start to end of the interventional procedure)

• Rate of Lesion Success

  On Day 0 (From the start to end of the interventional procedure)

• Rate of Individual Procedural Parameters

  On Day 0 (From the start to end of the interventional procedure)

• Rate of Major Adverse Cardiac Event (MACE)

  In-Hospital (1 - 3 Days)

• Rate of Target Lesion Failure (TLF)

  In-Hospital (1 - 3 Days)

Study Arms (1)

MINI TREK RX 1.20 mm Coronary Dilatation Catheter

Patients requiring initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis will be included.

Device: MINI TREK RX 1.20 mm Coronary Dilatation Catheter

Interventions

MINI TREK RX 1.20 mm Coronary Dilatation Catheter DEVICE

Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions

MINI TREK RX 1.20 mm Coronary Dilatation Catheter

Eligibility Criteria

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

Study Population

Subjects will be enrolled at 4 sites in the United States (US). At each site, at least two different qualified physicians will perform the index procedures. Approximately 30% of the enrolled subjects will be females.

You may qualify if:

• Subject must be at least 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
• Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
• Subject must have single or multiple vessel coronary artery disease with clinical evidence of myocardial ischemia (e.g., stable or unstable angina or silent ischemia documented by a positive functional study).
• Subject must be an acceptable candidate for CABG.
• Subject must agree to undergo all protocol-required follow-up procedures.
• Subject must agree not to participate in any other clinical study during hospitalization for the index procedure.
• De novo or restenotic lesions in native coronary arteries or bypass grafts.
• A maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Tandem lesions, defined as multiple, focal lesions that can be covered by one stent, will be considered as a single lesion.
• If one target lesion and one non-target lesion are to be treated, the target and non-target lesions must be located in different major epicardial distribution trees.
• The target lesion must have a diameter stenosis of ≥ 70% by visual estimation or online quantitative coronary angiography (QCA), which may include chronic total occlusion (CTO).
• Lesions may be located in highly tortuous vessels.

You may not qualify if:

• Subject has had a known diagnosis of an acute myocardial infarction (AMI) within 72 hours preceding the intended index procedure.
• The subject is currently experiencing clinical symptoms consistent with a new onset of AMI, such as prolonged chest pain with ischemic ECG changes unresponsive to nitrates.
• Subject has hemodynamic instability or any hemodynamically unstable cardiac arrhythmias.
• Subject has a known left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
• Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
• Subject will require Low Molecular Weight Heparin (LMWH) within 8 hours before or at any time after the index procedure.
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Subject has a platelet count \< 100,000 cells/mm\^3 or \> 700,000 cells/mm\^3.
• Subject has a serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure.
• Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had active peptic ulcer or a significant gastrointestinal or urinary bleed within the past six months.
• Elective surgery is planned during hospitalization for the index procedure that will require discontinuing dual anti-platelet therapy.
• Subject has other medical illness (e.g., cancer) that may confound the data interpretation or is associated with a limited life expectancy.
• Subject is currently participating in an investigational study when such participation could confound the treatment or outcomes of this study.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (4)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21804, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• Kandzari DE, Teirstein PS, Kereiakes DJ, Cannon LA, Hearne SE, Kuo HC, Ying SW, Cheong WF, Popma JJ. Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes. J Interv Cardiol. 2013 Apr;26(2):131-6. doi: 10.1111/j.1540-8183.2013.12021.x. Epub 2013 Jan 31.

  PMID: 23369084 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease

Results Point of Contact

• Title: Jessie Coe
• Organization: Abbott Medical Devices

Jessie.coe@abbott.com

224 668 5360

Study Officials

• David E Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 23, 2010
• Study Start: August 12, 2010
• Primary Completion: December 30, 2010
• Study Completion: December 30, 2010
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-01

Locations

US (4)