N/A
Completed N=60
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Source: ClinicalTrials.gov NCT04865588 ↗Enrolled (actual)
60
Serious AEs
13.3%
Results posted
May 2024
Primary outcomePrimary: Minimum Stent Area After Percutaneous Coronary Intervention — 6.7; 6.9 mm^2
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 atherectomy 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum Stent Area After Percutaneous Coronary Intervention |
6.7; 6.9 | — |
| SECONDARY In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation |
5.9; 6.4 | — |
| SECONDARY Minimum Percent Stent Expansion After Percutaneous Coronary Intervention |
86.1; 78.6 | — |
| SECONDARY Mean Percent Stent Expansion After Percutaneous Coronary Intervention |
112.5; 104.2 | — |
| SECONDARY Number of Participants With Dissection After Percutaneous Coronary Intervention |
1; 3 | — |
| SECONDARY Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention |
5; 9 | — |
| SECONDARY Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA) |
27; 30 | — |
| SECONDARY Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon |
14; 7 | — |
| SECONDARY Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography |
1.0; 1.1 | — |
| SECONDARY Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography |
1.5; 1.6 | — |
| SECONDARY Percent Residual Diameter Stenosis In-segment After Stent Implantation |
25.8; 28.4 | — |
| SECONDARY Percent Residual Diameter Stenosis In-stent After Stent Implantation |
13.8; 14.8 | — |
| SECONDARY Minimum Lumen Diameter In-segment After Stent Implantation |
2.1; 2.1 | — |
| SECONDARY Minimum Lumen Diameter In-stent After Stent Implantation |
2.5; 2.5 | — |
| SECONDARY Number of Participants With Dissection Type B or Greater |
6; 13; 0; 1 | — |
| SECONDARY Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation |
0; 0 | — |
| SECONDARY Number of Participants With Side Branch Closure After Stent Implantation |
0; 0 | — |
| SECONDARY Number of Participants With a Balloon Rupture |
0; 0 | — |
| SECONDARY Number of Participants With Blade Detachment |
0; 0 | — |
| SECONDARY Number of Participants With Difficulty in Withdrawing/Advancing the Device |
0; 0 | — |
| SECONDARY Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention |
1; 0 | — |
| SECONDARY Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention |
26.9; 13.2 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention |
1; 0 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention |
1; 0 | — |
| SECONDARY Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Number of Participants With Vascular Complications After Percutaneous Coronary Intervention |
0; 0 | — |
| SECONDARY Angina Status According to Canadian Cardiovascular Society (CSS) Classification |
— | — |
Eligibility 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, 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)
Data sourced from ClinicalTrials.gov (NCT04865588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.