Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions

NCT05848232 | Unknown Phase 3 FDA Device

• 1 other identifier: CP-009
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials. Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.

Conditions

Coronary Occlusion

Outcome Measures

Primary Outcomes (1)

• Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE)

  * Technical success is defined as angiographic confirmation of chronic total occlusion crossing with guidewire placement, facilitated by one or more of the Cora Catheters, in the target vessel true lumen either distal or proximal to the occlusion, depending on the route of access. * MACE includes cardiac death, myocardial infarction {Q-wave or non-Q-wave, with CK-MB \>3 times upper limit of normal}, and target lesion revascularization

  Through hospital discharge or 24 hours post-procedure (whichever comes first)

Study Arms (1)

coraFlex, coraForce, and/or coraCross Catheters

EXPERIMENTAL

Single arm

Device: coraFlex Catheter; Device: coraForce Catheter; Device: coraCross Catheter

Interventions

coraFlex Catheter DEVICE

The coraFlex catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.

coraFlex, coraForce, and/or coraCross Catheters

coraForce Catheter DEVICE

The coraForce catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.

coraFlex, coraForce, and/or coraCross Catheters

coraCross Catheter DEVICE

The coraCross catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond occluded coronary lesions.

coraFlex, coraForce, and/or coraCross Catheters

Eligibility Criteria

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

You may qualify if:

• Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
• Male or non-pregnant female ≥18 years of age at time of consent.
• Subjects experiencing clinical symptoms suggestive of ischemic heart disease or has evidence of myocardial ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.
• Subject is a candidate for PTCA, stenting, and emergency CABG.
• A minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting CTO criteria {defined as TIMI grade 0 flow} and estimated to be \> 3 months duration by clinical history and/or comparison with a prior angiogram or electrocardiogram.

You may not qualify if:

• Subject unwilling or unable to comply with the protocol or follow-up requirements, in the opinion of the investigator.
• Subject life expectancy less than one year, in the opinion of the investigator.
• Subject is pregnant or planning to become pregnant during the course of the trial.
• Evidence of MI within 72 hours prior to the index procedure.
• History of stroke or transient ischemic attack within 6 months prior to the index procedure.
• Prior coronary interventional procedure (including coronary artery bypass graft surgery) of any kind within 30 days of the index procedure.
• Inability to tolerate DAPT with aspirin plus a P2Y12 inhibitor.
• Known allergies or sensitivities to heparin, antiplatelet drugs, or other anticoagulant therapies, which could not be substituted, including history of major bleeding event in the last 6 months.
• Allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the index procedure.
• Subjects with known history of clinically significant abnormal laboratory findings ≤30 days prior to enrollment including:
• Neutropenia (\<1000 neutrophils/mm3)
• Thrombocytopenia (\<100,000 platelets/mm3)
• AST, ALT, ALP, or bilirubin \> 1.5 times ULN
• Serum creatinine \> 2.0 mg/dL
• Subject has signs/symptoms of systemic infection/sepsis (temperature ≥ 38.00 Celsius and WBC ≥12,000 cells/µL). If subject has localized infection or infection is adequately treated and controlled, per investigator discretion, patient may be enrolled.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lorenzo Azzalini, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Finton

CONTACT

616-633-9178; sfinton@reflowmedical.com

Vicky Joshi

CONTACT

vjoshi@reflowmedical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)