MedDataX Logo

One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG

NCT ID: NCT06179329

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the "no-touch" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Disease Surgery-Complications Graft Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiovascular Surgery Coronary Disease Women Graft patency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radial - Anterolateral / Saphenous - RCA

Radial artery graft for the anterolateral wall, and "no-touch" saphenous vein graft for the right coronary artery territory

Group Type OTHER

Coronary artery bypass graft

Intervention Type PROCEDURE

Randomization will be performed for stratification according to the target coronary arteries and the randomly determined block size from 4 to 6. The randomization result will be delivered in a sealed envelope in the operating room (before the time out) for one of the two drawn strategies.

Radial - RCA / Saphenous - Anterolateral

Radial artery graft for the territory of the right coronary artery and "no-touch" saphenous vein for the anterolateral wall.

Group Type OTHER

Coronary artery bypass graft

Intervention Type PROCEDURE

Randomization will be performed for stratification according to the target coronary arteries and the randomly determined block size from 4 to 6. The randomization result will be delivered in a sealed envelope in the operating room (before the time out) for one of the two drawn strategies.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coronary artery bypass graft

Randomization will be performed for stratification according to the target coronary arteries and the randomly determined block size from 4 to 6. The randomization result will be delivered in a sealed envelope in the operating room (before the time out) for one of the two drawn strategies.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Women aged 18 years or older and younger than 70 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.

Exclusion Criteria

1. Preoperative conditions:

1. Lack of the patient's written informed consent.
2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \>7 mg/dl.
3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.
4. Renal failure with glomerular filtration rate (creatinine clearance) \<30 mL/min.
2. Inability to use the saphenous and/or radial vein

1. Positive Allen test using a pulse oximeter
2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.
3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal
3. Conditions that may affect patient follow-up

1. Presence of advanced peripheral arterial disease
2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.
3. Impossibility of tracking due to geographic inaccessibility.
4. Patients with lack of adherence to guidelines and/or prescribed medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Regional São Paulo

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Cardiologia

UNKNOWN

Sponsor Role collaborator

Hospital Unimed João Pessoa

UNKNOWN

Sponsor Role collaborator

Hospital do Coração de Messejana

UNKNOWN

Sponsor Role collaborator

Hospital do Coração Alagoano Prof. Adib Jatene

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Omar AV Mejia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar A V Mejia, MD, PhD

Role: CONTACT

Phone: +551126615014

Email: [email protected]

Leonardo L Lacava, MD

Role: CONTACT

Phone: +55 49 33224453

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Omar AV Mejia, MD, PhD

Role: primary

Fabiane L Freitas, BsC

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5723/23/125

Identifier Type: -

Identifier Source: org_study_id