Trial · NCT03952273
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
NCT03952273, Not applicable, Active not recruiting, Phillip Freeman
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent. Trials, record NCT03952273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03952273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent
- NCT number
- NCT03952273
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 3,141 participants, actual
- Lead sponsor
- Phillip Freeman
- Conditions
- Coronary Artery Disease
- Interventions
- PCI with BioMatrix Alpha™ stent, PCI with Combo™ stent
- First posted
- 2019-05-16
- Last updated
- 2023-04-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization | Within 12 months | The primary endpoint will be analyzed using the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the ComboTM stent will be used as the reference group. |
| Primary | Target Lesion Revascularisation (TLR) | Within 12 months | Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90). TLR will be clinically driven. |
| Secondary | Individual components of the primary end point comprise the secondary end points | Clinical follow-up will be continued through 5 years | cardiac death; MI; clinically indicated TLR; all death (cardiac and noncardiac) and target vessel revascularisation (TVR); definite, probable, possible, and overall stent thrombosis according to the Academic Research Consortium definition (22); and a patient-related composite end point (all death, all MI (including procedure related MI), or any revascularization). For continuous variables, the difference between the treatment groups will be evaluated using Wilcoxon's rank-sum test. For discrete variables, the differences will be given as numbers and in percentages and will be analyzed using Fisher's exact test. Two-sided test will be used, and a pvalue of 0.05 considered significant. |
| Secondary | Number of participants with Cardiac Death | Through 5 years | |
| Secondary | Number of participants with Myocardial Infarction | Through 5 years | The acute MI diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of MI" (23), which has been adapted by Academy Research Consortium (22). In cases of updates of the definition of MI, the latest definition will be used. |
| Secondary | Target Lesion Revascularization due to clincal symptoms | Through 5 years | Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90. |
| Secondary | Number of patients with all cause mortality | Through 5 years | Cardiac and non-cardiac |
| Secondary | Target Vessel Revascularization due to clincal symptoms | Through 5 years | Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90. |
| Secondary | Number of patients with stent thrombosis | Through 5 years | Definite, probable, possible and overall according to the Academic Research Consortium definition (22) |
| Secondary | Number of patients with Patient-related composite end point | Through 5 years | All death, all MI (including procedure related MI) or any revascularisation |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03952273
GET https://conductscience.org/api/trials/v1/NCT03952273/registered