Clinical trial NCT02819531: Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions
Official title: A Single Center, Randomized Trial of Treatment Strategies for Obstructive Calcified Coronary Lesions: Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions (ECSPAND)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Coronary Atherectomy
percutaneous coronary intervention
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2016-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of final in-stent minimum lumen area/reference lumen area
timeFrame: Immediately after stenting
Secondary outcomes:
measure: Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)
timeFrame: Immediately after stenting
measure: Mean final minimal stent area (MSA)
timeFrame: Immediately after stenting
measure: Ratio of final in-stent minimum lumen diameter/reference lumen diameter
timeFrame: Immediately after stenting
measure: Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up
timeFrame: 30 days
measure: Procedure time
timeFrame: Immediately after the end of the interventional procedure
measure: Fluoroscopy time
timeFrame: Immediately after the end of the interventional procedure
measure: Contrast volume
timeFrame: Immediately after the end of the interventional procedure
Other outcomes:
Locations:
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_CHAIR
affiliation: North Texas Veterans Healthcare System
name: Jerrold Grodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Genereux P, Lee AC, Kim CY, Lee M, Shlofmitz R, Moses JW, Stone GW, Chambers JW. Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am J Cardiol. 2015 Jun 15;115(12):1685-90. doi: 10.1016/j.amjcard.2015.03.009. Epub 2015 Mar 24.
citation: Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010 Jun;23(3):240-8. doi: 10.1111/j.1540-8183.2010.00547.x.
citation: Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol. 2001 Sep;38(3):672-9. doi: 10.1016/s0735-1097(01)01458-9.
citation: Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.