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

Veterans Affairs (VA) North Texas Health Care System

Status: Unknown

Conditions: Coronary Artery Disease; Atherosclerosis

Treatments: Device: Orbital atherectomy; Device: Rotational atherectomy; Device: Scoring balloon system

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02819531

16-017

Details and patient eligibility

About

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)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Rotational atherectomy

Active Comparator group

Description:

RA protocol: After IVUS protocol, patients who are randomized to RA will undergo coronary wiring of the target lesion 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.

Treatment:

Device: Rotational atherectomy

Orbital atherectomy

Active Comparator group

Description:

OAS protocol: After IVUS protocol, patients who are randomized to OAS will undergo coronary wiring of the target lesion and subsequent advancement of the OAS according to the manufacturer's guidelines.

Treatment:

Device: Orbital atherectomy

Scoring balloon system

Active Comparator group

Description:

SBS protocol: After IVUS protocol, patients who are randomized to SBS will undergo coronary wiring of the target lesion and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the manufacturer's guidelines.

Treatment:

Device: Scoring balloon system