ROTA-CUT: Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Study Details
Study Description
Brief Summary
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational artherectomy with the addition of a cutting balloon
- a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational artherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.
The clinical investigation will be conducted at 2 centers in the US. 30 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: rotational atherectomy + cutting balloon angioplasty with rotational atherectomy followed by cutting balloon |
Procedure: rotational atherectomy
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
Device: cutting balloon
a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
|
Active Comparator: rotational atherectomy + plain old balloon angioplasty with rotational atherectomy followed by plain old balloon |
Procedure: rotational atherectomy
angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
Device: plain old balloon
current standard treatment of stent placement
|
Outcome Measures
Primary Outcome Measures
- Minimum Stent Area after Percutaneous Coronary Intervention [Day 0]
mm^2
Secondary Outcome Measures
- In-segment Minimum lumen area after stent implantation [Day 0]
mm^2
- In-segment Minimum lumen area assessed post-dilatation [Day 0]
mm^2
- Minimum stent expansion after Percutaneous Coronary Intervention [Day 0]
mm^2
- Mean stent expansion after Percutaneous Coronary Intervention [Day 0]
in %
- Number of Participants with Dissection [Day 0]
A dissection or tear in the vessel wall
- Number of Participants with Stent fracture [Day 0]
Stent fracture as a cause of drug-eluting stent failure
- Number of Participants with Stent malapposition [Day 0]
Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall.
- Acute lumen gain after stent implantation [Day 0]
defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).
Eligibility Criteria
Criteria
Inclusion Criteria
-
Adults Patients ≥18 years of age
-
Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
-
Patients eligible for percutaneous coronary intervention
Exclusion Criteria
-
Patients in cardiogenic shock
-
Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
-
Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
-
Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception
-
Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months
-
Currently participating in another investigational drug or device study
-
Patients referred to coronary artery bypass grafting after heart team discussion
Angiographic Specific Exclusion Criteria:
-
Lesion(s) with angulation > 45 degrees by visual estimate
-
Lesion(s) stenosis through which a guidewire will not pass.
-
Last remaining vessel with compromised (<30%) left ventricular function
-
Saphenous vein grafts
-
Angiographic evidence of thrombus
-
Angiographic evidence of significant dissection at the treatment site
-
Lesion(s) with previously placed stent within 10 mm (visual estimate)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
2 | Saint Francis Hospital and Heart Center | Roslyn | New York | United States | 11576 |
Sponsors and Collaborators
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Investigators
- Principal Investigator: Samin K Sharma, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GCO 21-0532