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Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions

NCT02819531 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-07

No results posted yet for this study

Summary

Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the study.

Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.

Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent advancement of the OAS according to the manufacturer's guidelines.

Control: Patients who are randomized to SBS will undergo coronary wiring and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the AngioSculpt manufacturer's guidelines.

Duration: 30 days follow-up.

The primary trial objective is to determine which of the three treatment strategies for treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT (primary study endpoint).

The secondary objectives are to compare the following:

1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as determined by IVUS or OCT (secondary endpoint)
2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)
3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined by quantitative coronary angiography (secondary endpoint)
4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up (secondary endpoints)
5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)

Conditions

Interventions

DEVICE

Rotational atherectomy

Pre-stenting lesion modification using the rotational atherectomy device using standard technique under intravenous infusion of heparin. Burr size will be selected by the operator according to vessel size. IVUS images will be obtained before lesion modification and after stenting.

DEVICE

Orbital atherectomy

Pre-stenting lesion modification using the orbital atherectomy device according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.

DEVICE

Scoring balloon system

Pre-stenting lesion modification using the scoring balloon system according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · North Texas Veterans Healthcare System

  • Jerrold Grodin, MD · North Texas Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02819531 on ClinicalTrials.gov