Prevention of Restenosis Following Revascularization
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2009-09-30, after 2008-01-31 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2009-09-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: greateror equalequal topatientpain
Phrases that lowered it: mildmoderateparticipation inclinicalmale -
Sponsor's past termination rate: 26.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: prevention (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 17.9% (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 90.6% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 19 (typical: 32)
- Sponsor's past termination rate
- 26.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2884 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 699 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- paclitaxel
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia NCT02260622 · started 2014 · scored riskier than 36% of active trials completed
- Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH) NCT01099215 · started 2010 · scored riskier than 77% of active trials completed
- Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK) NCT02956993 · started 2016 · scored riskier than 47% of active trials completed
- RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty NCT03064126 · started 2017 · scored riskier than 80% of active trials completed
- Edoxaban in Peripheral Arterial Disease NCT01802775 · started 2013 · scored riskier than 66% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.