Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

Not Applicable

Completed

Conditions: Coronary Artery Disease

Registration Number: NCT01092416

Lead Sponsor: Abbott Medical Devices

Brief Summary: This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 443

Inclusion Criteria

Subjects must be 18 or older.
Subjects must have a clinical indication for coronary intervention.
CK and CK-MB must be less than or equal to the upper limit of lab normal value within 8 hours prior to the procedure.
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
The target vessel must be a native coronary artery with a stenosis of >= 70% and < 100%.
The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
The lesion length must not exceed 40 mm.
The target vessel must have a TIMI flow 3 at baseline.
The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion.
The lesion must be crossable with the study guide wire.

Exclusion Criteria

Inability to understand the study or a history of non-compliance with medical advice.
Unwilling or unable to sign the ORBIT II Informed Consent Form (ICF).
History of any cognitive or mental health status that would interfere with study participation.
Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
Female subjects who are pregnant or planning to become pregnant within the study period.
Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
Known sensitivity to contrast media, which cannot be adequately pre-medicated.
Diagnosed with chronic renal failure or has a serum creatinine level >2.5 mg/dl.
Experienced acute MI (STEMI or non-STEMI: CK and CK-MB greater than 1 times the upper limit of lab normal) within 30 days prior to index procedure.
History of major cardiovascular intervention within 30 days.
Evidence of current (within 6 months) left ventricular ejection fraction ≤ 25%.
NYHA class III or IV heart failure.
History of a stroke or transient ischemic attack (TIA) within 6 months.
Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months.
History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary.
Concurrent medical condition with a life expectancy of less than 12 months.
History of immune deficiency.
Uncontrolled insulin dependent diabetes.
Evidence of active infections on the day of the index procedure.
Subject has planned cardiovascular intervention within 60-days post index procedure.
Subject is not an acceptable candidate for emergent coronary artery bypass surgery.
Subject with known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
Subject with 3 lesions requiring intervention.
Subject with 2 lesions unless the treatment of the lesions is staged. The non target lesion must first be treated at least 12 hours prior to the index procedure. The subject's CK and CK-MB must be less than or equal to one times the upper limit of the lab normal value 12 ± 2 hours post procedure and there were no procedural complications during the first lesion intervention.
Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass.
Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line QCA.
Target vessel has angiographically visible or suspected thrombus.
Target vessel has a stent from previous PCI.
Target vessel is excessively tortuous.
Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
Target lesion is a bifurcation.
Target lesion has a ≥ 1.5 mm side branch.
Angiographic evidence of a dissection prior to OAS treatment.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)	30 days	OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Primary Efficacy Endpoint: Procedural Success	Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.	Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.

Secondary Outcome Measures

Name	Time	Method
Severe Angiographic Complications	Baseline procedure, with a mean total procedure time of 52.5 minutes.	Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
12-Month Freedom From Major Adverse Cardiac Events (MACE)	12 months	The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.
Angiographic Success	Baseline procedure, with a mean total procedure time of 52.5 minutes.	Angiographic success was defined as success in facilitating stent delivery with \<50% residual stenosis and without severe angiographic complications.

Trial Locations

Locations (51): Mercy Gilbert
🇺🇸
Gilbert, Arizona, United States
Desert Cardiology Center
🇺🇸
Rancho Mirage, California, United States
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Lakeland
🇺🇸
Saint Joseph, Michigan, United States
Indiana Heart Hospital
🇺🇸
Indianapolis, Indiana, United States
Saint Vincents Indianapolis
🇺🇸
Indianapolis, Indiana, United States
Abbott Northwestern
🇺🇸
Minneapolis, Minnesota, United States
St. Luke's
🇺🇸
Houston, Texas, United States
Trinity Hospital
🇺🇸
Birmingham, Alabama, United States
Detroit Medical Center
🇺🇸
Detroit, Michigan, United States
St. John's Hospital
🇺🇸
Detroit, Michigan, United States
Oklahoma Heart
🇺🇸
Oklahoma City, Oklahoma, United States
Baptist Montgomery South
🇺🇸
Montgomery, Alabama, United States
Cedar Sinai Los Angeles
🇺🇸
Beverly Hills, California, United States
Eisenhower Medical Center
🇺🇸
Palm Springs, California, United States
Good Samaritan Hospital
🇺🇸
Los Angeles, California, United States
Sutter Memorial Hospital
🇺🇸
Sacramento, California, United States
Florida Hospital Memorial
🇺🇸
Daytona Beach, Florida, United States
North Florida Regional
🇺🇸
Gainesville, Florida, United States
Orlando Regional
🇺🇸
Orlando, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Munroe Regional Medical Center
🇺🇸
Ocala, Florida, United States
Winter Haven
🇺🇸
Winter Haven, Florida, United States
Palm Beach Gardens
🇺🇸
Palm Beach Gardens, Florida, United States
Iowa Heart
🇺🇸
Des Moines, Iowa, United States
Community Hospital
🇺🇸
Munster, Indiana, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
King's Daughters / Kentucky Heart Foundation
🇺🇸
Ashland, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Cape Cod Research Institute
🇺🇸
Hyannis, Massachusetts, United States
St. Joseph Mercy
🇺🇸
Pontiac, Michigan, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Mercy Hospital
🇺🇸
Coon Rapids, Minnesota, United States
Saint Michaels
🇺🇸
Newark, New Jersey, United States
United Heart & Vascular
🇺🇸
Saint Paul, Minnesota, United States
Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Lenox Hill
🇺🇸
New York, New York, United States
St. Francis
🇺🇸
Roslyn, New York, United States
Good Samaritan Dayton
🇺🇸
Dayton, Ohio, United States
Bryn Mawr / Lankenau
🇺🇸
Bryn Mawr, Pennsylvania, United States
The Heart and Vascular Center
🇺🇸
Beaver, Pennsylvania, United States
St. Mary's
🇺🇸
Langhorne, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Baptist Memorial Hospital-DeSoto
🇺🇸
Memphis, Tennessee, United States
Baylor
🇺🇸
Dallas, Texas, United States
Memorial Hermann
🇺🇸
Houston, Texas, United States
Davis Hospital
🇺🇸
Layton, Utah, United States
Saint Joe Bellingham / North Cascade Cardiology
🇺🇸
Bellingham, Washington, United States
New York Methodist Hospital
🇺🇸
Brooklyn, New York, United States