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

NCT02819531 | Unknown DMC

• 1 other identifier: 16-017
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

Coronary Atherectomy; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)

  Immediately after stenting

• Mean final minimal stent area (MSA)

  Immediately after stenting

• Ratio of final in-stent minimum lumen diameter/reference lumen diameter

  Immediately after stenting

• Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up

  30 days

• Procedure time

  Immediately after the end of the interventional procedure

Study Arms (3)

Rotational atherectomy

ACTIVE COMPARATOR

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.

Device: Rotational atherectomy

Orbital atherectomy

ACTIVE COMPARATOR

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.

Device: Orbital atherectomy

Scoring balloon system

ACTIVE COMPARATOR

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.

Device: Scoring balloon system

Interventions

Rotational atherectomy DEVICE

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.

Rotational atherectomy

Orbital atherectomy DEVICE

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.

Orbital atherectomy

Scoring balloon system DEVICE

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.

Scoring balloon system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study
• 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

You may not qualify if:

• Subject is currently participating in an investigational device or pharmaceutical treatment protocol
• Persistent (\>10 minutes) hypotension (systolic blood pressure \<90 mmHg)
• Need for revascularization of multiple lesions during the index PCI
• Unprotected left main (\>50%) or equivalent left main disease
• Non-calcified lesions
• Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions
• Severe left ventricular dysfunction (ejection fraction \<25%)
• History of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Related Publications (4)

• 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.

  PMID: 25910525 BACKGROUND

• 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.

  PMID: 20636844 BACKGROUND

• 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.

  PMID: 11527615 BACKGROUND

• 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.

  PMID: 24561145 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  STUDY CHAIR

• Jerrold Grodin, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Laboratories, Professor of Medicine

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share