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

Coronary Artery Disease Clinical Trial

— ORBIT II  

Official title:

Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092416
• Other study ID #: ORBIT II
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: January 2016

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: January 2016
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Diamondback 360 Orbital Atherectomy System
Diamondback 360 Orbital Atherectomy System. The (OAS) utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces (up to a maximum orbit diameter for a given rotational speed and crown diameter). It is a minimally invasive PCI procedure.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (15)

Chambers JW, Feldman RL, Himmelstein SI, Bhatheja R, Villa AE, Strickman NE, Shlofmitz RA, Dulas DD, Arab D, Khanna PK, Lee AC, Ghali MG, Shah RR, Davis TP, Kim CY, Tai Z, Patel KC, Puma JA, Makam P, Bertolet BD, Nseir GY. Pivotal trial to evaluate the sa — View Citation

Genereux P, Bettinger N, Redfors B, Lee AC, Kim CY, Lee MS, Shlofmitz RA, Moses JW, Stone GW, Chambers JW. Two-year outcomes after treatment of severely calcified coronary lesions with the orbital atherectomy system and the impact of stent types: Insight — View 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. do — View Citation

Kim CY, Lee AC, Wiedenbeck TL, Lee MS, Chambers JW. Gender differences in acute and 30-day outcomes after orbital atherectomy treatment of de novo, severely calcified coronary lesions. Catheter Cardiovasc Interv. 2016 Mar;87(4):671-7. doi: 10.1002/ccd.261 — View Citation

Lee M, Genereux P, Shlofmitz R, Phillipson D, Anose BM, Martinsen BJ, Himmelstein SI, Chambers JW. Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial. Cardiovasc Revasc Med. 2017 Jun — View Citation

Lee MS, Anose BM, Martinsen BJ, Lee AC, Shlofmitz RA, Chambers JW. Orbital atherectomy treatment of severely calcified native coronary lesions in patients with prior coronary artery bypass grafting: Acute and one-year outcomes from the ORBIT II trial. Car — View Citation

Lee MS, Lee AC, Shlofmitz RA, Martinsen BJ, Hargus NJ, Elder MD, Genereux P, Chambers JW. ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System. Catheter Car — View Citation

Lee MS, Martinsen BJ, Lee AC, Behrens AN, Shlofmitz RA, Kim CY, Chambers JW. Impact of diabetes mellitus on procedural and one year clinical outcomes following treatment of severely calcified coronary lesions with the orbital atherectomy system: A subanal — View Citation

Lee MS, Martinsen BJ, Shlofmitz R, Shlofmitz E, Lee AC, Chambers J. Orbital atherectomy treatment of severely calcified coronary lesions in patients with impaired left ventricular ejection fraction: one-year outcomes from the ORBIT II study. EuroIntervent — View Citation

Lee MS, Shlofmitz E, Shlofmitz R, Sahni S, Martinsen B, Chambers J. Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study. J Invasive Cardiol. 2016 Sep;28(9):364-9. Epub 2016 Mar 15. — View Citation

Lee MS, Shlofmitz RA, Martinsen BJ, Sethi S, Chambers JW. Impact of age following treatment of severely calcified coronary lesions with the orbital atherectomy system: 3-year follow-up. Cardiovasc Revasc Med. 2018 Sep;19(6):655-659. doi: 10.1016/j.carrev. — View Citation

Lee MS, Shlofmitz RA, Shlofmitz E, Behrens AN, Revtyak G, Martinsen BJ, Chambers JW. Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jul;20(7):5 — View Citation

Lee MS, Shlofmitz RA, Shlofmitz E, Srivastava PK, Kong J, Grines C, Revytak G, Chambers JW. Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. Cardiovasc Revasc Med. 2018 Apr;19(3 Pt A):268-2 — View Citation

Shlofmitz E, Martinsen B, Lee M, Genereux P, Behrens A, Kumar G, Puma J, Shlofmitz R, Chambers J. Utilizing intravascular ultrasound imaging prior to treatment of severely calcified coronary lesions with orbital atherectomy: An ORBIT II sub-analysis. J In — View Citation

Shlofmitz E, Martinsen BJ, Behrens AN, Ali ZA, Lee MS, Puma JA, Shlofmitz RA, Chambers JW. Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis. Cardiovasc Revasc Med. 2019 Jun;20(6):454-460. doi: 10.1016/j.carrev.2019.03. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)	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.	30 days
Primary	Primary Efficacy Endpoint: Procedural Success	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.	Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.
Secondary	Angiographic Success	Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.	Baseline procedure, with a mean total procedure time of 52.5 minutes.
Secondary	Severe Angiographic Complications	Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.	Baseline procedure, with a mean total procedure time of 52.5 minutes.
Secondary	12-Month Freedom From Major Adverse Cardiac Events (MACE)	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.	12 months