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

Coronary Artery Disease Clinical Trial

— ECSPAND  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02819531
• Other study ID #: 16-017
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 21, 2016
• Last updated: April 5, 2017
• Start date: June 2016

Study information

• Verified date: April 2017
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

References & Publications (4)

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. — View Citation

Généreux 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. — View Citation

Généreux 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of final in-stent minimum lumen area/reference lumen area	IVUS measurement based determination of ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS	Immediately after stenting
Secondary	Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)	IVUS measurement based determination of difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)	Immediately after stenting
Secondary	Mean final minimal stent area (MSA)	IVUS measurement based determination of Mean final minimal stent area (MSA)	Immediately after stenting
Secondary	Ratio of final in-stent minimum lumen diameter/reference lumen diameter	Quantitative coronary angiography based determination of ratio of final in-stent minimum lumen diameter/reference lumen diameter	Immediately after stenting
Secondary	Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up		30 days
Secondary	Procedure time		Immediately after the end of the interventional procedure
Secondary	Fluoroscopy time		Immediately after the end of the interventional procedure
Secondary	Contrast volume		Immediately after the end of the interventional procedure