Atherosclerosis, Coronary Artery Disease
Conditions
Keywords
Coronary Atherectomy, percutaneous coronary intervention
Brief 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)
Interventions
DEVICERotational 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.
DEVICEOrbital 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.
DEVICEScoring 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
North Texas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study 3. Found to have a de novo severe calcification (radio opacities noted without cardiac motion on contrast injection, lesion length \>15 mm, or presence of \>270° calcification on one cross-sectional view of IVUS) in a native coronary artery on fluoroscopy or IVUS
Exclusion criteria
1. Subject is currently participating in an investigational device or pharmaceutical treatment protocol 2. Persistent (\>10 minutes) hypotension (systolic blood pressure \<90 mmHg) 3. Need for revascularization of multiple lesions during the index PCI 4. Unprotected left main (\>50%) or equivalent left main disease 5. Non-calcified lesions 6. Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions 7. Severe left ventricular dysfunction (ejection fraction \<25%) 8. History of bleeding diathesis or coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of final in-stent minimum lumen area/reference lumen area | Immediately after stenting | IVUS measurement based determination of ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean final minimal stent area (MSA) | Immediately after stenting | IVUS measurement based determination of Mean final minimal stent area (MSA) |
| Ratio of final in-stent minimum lumen diameter/reference lumen diameter | Immediately after stenting | Quantitative coronary angiography based determination of ratio of final in-stent minimum lumen diameter/reference lumen diameter |
| Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up | 30 days | — |
| Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain) | Immediately after stenting | IVUS measurement based determination of difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain) |
| Fluoroscopy time | Immediately after the end of the interventional procedure | — |
| Contrast volume | Immediately after the end of the interventional procedure | — |
| Procedure time | Immediately after the end of the interventional procedure | — |
Outcome results
None listed