Coronary Artery DiseasePROCTORNCT03805048
PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior CABG
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 21 sites in 5 countries.
Trial summary
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 22 Jan 2019to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A significant stenosis (>50% on angiography) in a venous bypass graft
- The native lesion must be bypassed by a single graft or must be connected to a jump graft at the most distal anastomosis of that graft
- In jumpgraft lesions, the lesion must be located distally to the second-to-last anastomosis
- Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
- Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
- Informed consent must be obtained
Who cannot join
- < 18 years of age
- Target vessel diameter < 2.5 mm
- CABG performed less than 1 year prior to inclusion
- Diameter of the graft > 5.5 mm
- Aneurysm formation in the bypass graft
- Heavy burden of thrombus in the bypass graft (>50% of the bypass graft lumen in ≥2 out of 3 of the proximal, middle or distal third of the bypass graft).
Show all 13Show fewer
- STEMI at presentation
- NSTEMI patients with ongoing ischemia
- Cardiogenic shock
- Severe kidney disease defined as an eGFR < 30 ml/min.
- Pregnancy
- Estimated life expectancy < 3 year
- Contraindications to PCI
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Netherlands8 sites
Universitair Medische Centra
Amsterdam, 1081 HV
Academic Medical Center
Amsterdam, 1105
Amphia Ziekenhuis
Breda, 4818 CK
Catharina Ziekenhuis
Eindhoven
Medisch Centrum Leeuwarden
Leeuwarden, 8934
Sint Antonius Ziekenhuis
Nieuwegein, 3435
Radboud Universitair Medisch Centrum (Radboud UMC)
Nijmegen
Universitair Medisch Centrum
Utrecht, 3584 CX
United Kingdom7 sites
Basildon & Thurrock University Hospitals (Essex CTC)
Basildon, SS16 5NL
Health and Social Care Trust
Belfast, BT8 8BH
The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Bournemouth, BH7 7DW
UH Bristol NHS Trust, Bristol Heart Institute
Bristol, BS1 3NU
Golden Jubilee National Hospital
Glasgow, G81 4HX
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, M23 9LT
Belgium4 sites
University Hospital
Antwerp, Edegem, B 2650
Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim
Antwerp, 2020
Ziekenhuis Oost-Limburg
Genk, B-3600
UZ Leuven
Leuven, 3000
Poland1 site
Narodowy Instytut Kardiologii Stefana Kardynała Wyszyńskiego Państwowy Instytut Badawczy
Warsaw, 04-628
About this study
Official title: PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.
Read the detailed description
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR registry is planned to be conducted too (details included in the flow chart).
CCTA substudy Selected patients will be approached for participation in the CCTA substudy of the trial. Participation in this substudy is optional. After written informed consent is obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed before the PCI procedure.
PROCTOR registry
Patients can be approached for the registry when :
- PCI have been deemed clinically indicated by the local hartteam, and
- both the lesions in the native vessel and the dysfunctional graft have been deemed technically feasible by the local hartteam,
- the patient does not meet the in- and exclusion criteria for the randomized PROCTOR study or declines to participate in the randomized study.
Patients will be approached for participation and will have one week to consider. Written informed consent is mandatory for participating in the registry. Patients will be followed by telephonic follow-up after 1, 3, and 5 years. No additional study procedures will be performed.
Study objectives:to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization.
- PROCTOR main study
- Investigate the clinical outcome of native vessel PCI vs. PCI of dysfunctional venous bypass graft with a clinical indication for revascularisation
- CCTA substudy
- Investigate prognostic value of CT-derived plaque characteristics for occurrence of MACE following bypass graft PCI
- Investigate value of CCTA in guidance of CTO PCI procedures
- PROCTOR Registry - Investigate long-term clinical outcomes in patients with dysfunctional venous bypass graft and an indication for PCI whom are not included in randomised main study.
All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Patients will be eligible for inclusion if revascularization is deemed clinically indicated and technically feasible for PCI by the local heart team. The indication for revascularization will be based on symptoms and evidence of ischemia and viability in the target vessel territory. The lesion in the native vessel must be bypassed by a single venous graft or must be connected to a jump graft at the most distal anastomosis of that graft. In jump grafts, the lesion must be located distally to the second-to-last anastomosis. In case both the lesion in the native vessel and the lesion in the graft are deemed technically feasible for PCI, patients will be eligible for inclusion in the randomized study after consideration of in- and exclusion criteria. Patients who do not meet these criteria or decline to participate in the randomized study will be approached for inclusion in the registry. Subsequently patients will be approached for study participation. After being informed, patients will have at least 24 hours to consider participation. An independent physician will be available for extra information, if desired. After obtaining written informed consent, patients will be randomized to either native vessel PCI or PCI of the venous bypass graft. In case of PCI failure, a second attempt can be performed by the operator within one month.
If feasible, it is possible to perform a second attempt in another high-volume center. When successful PCI cannot be accomplished in one or two attempts, cross-over to the other treatment arm may be used as bailout strategy to restore myocardial blood flow to the distal vascular bed of the vessel. Randomization will be performed using an interactive Web-based randomization system, Open Clinica. After 1 and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- Percutaneous Coronary Intervention, Dysfunctional venous bypass graft, Second generation DES, CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.
| Study group | Role | What they receive |
|---|---|---|
| Native Vessel PCI | Other | All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the native vessel will be performed according to current standard. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry. Receives: Procedure: Percutaneous coronary intervention |
| Graft PCI | Other | All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator. Receives: Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount and type of Major Adverse Cardiac Events
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
Measured: 3 year follow up
Secondary outcomes (13)
Amount and type of Major Adverse Cardiac Events
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
Measured: 1 and 5 year follow-up
Amount of patients that have passed away
Mortality score, all-cause mortality
Measured: 1, 3 and 5 year follow-up
Number of non-fatal myocardial infarctions
Any non-fatal myocardial infarction noticed
Measured: 1, 3 and 5 year follow-up
Number of clinically driven target lesion revascularizations
Any clinically driven target lesion revascularization noticed
Measured: 1, 3 and 5 year follow-up
Number of target vessel revascularizations
Any target vessel revascularization noticed.
Measured: 1, 3 and 5 year follow-up
Number of target vessel failure.
Any target vessel failure noticed
Measured: 1, 3 and 5 year follow-up
Number of non-fatal myocardial infarctions.
Any non-fatal myocardial infarction noticed.
Measured: >48 hours after PCI
Number of PCI-related myocardial infarctions.
Any PCI-related myocardial infarction noticed.
Measured: 1, 3 and 5 year follow-up
Specific angiographic outcome
Any of the following outcomes:
- Late lumen loss
- In-stent binary restenosis (≥50%)
- In-stent re-occlusion
- Difference in in-stent diameter stenosis between index procedure at inclusion, and at 3-year follow-up
Measured: 3-year follow up
Quality of life assessed by SAQ
The Seattle Angina Questionnaire is a self-assessment questionnaire where patients' physical limitations caused by angina are quantified, as well as the frequency of and changes in their symptoms, their satisfaction with treatment and how they perceive their Quality of Life. Each scale is transformed to a 0-100 scale. the higher the score, the better the patients functions/the higher the Quality of Life.
Measured: 1, 3 and 5 year follow-up
Quality of life assessed by CCS
Canadian Cardiovascular Society (CCS) Grading Scale measures whether patient have angina pectoris complaints, and to what extent patients experienced this. It uses a scale of 1-4 where 1 means angina pectoris (chest pain) only occurs with streneous, rapid or prolonged exertion, and 4 means angina is present during little physical effort or even during rest.
Measured: 1, 3 and 5 year follow-up
Quality of life assessed by RDS
Rose dyspnea scale questionnaire (RDS) measures dyspnea complaints, or shortness of breath. It consists of 4 questions about dysnpea complaints in the everyday life of patients. For every patient, a score is compiled of the highest limitation in daily life, resulting in a score of 0-4, where 0 means no dyspnea complaints and 4 means the patient has complaints during no or minimal physical effort.
The scores from these questionnaires will be combined by summing the total scores.
Measured: 1, 3 and 5 year follow-up
Composite score of quality of life
Composite of all quality of life questionnaires, where all outcomes are summed to provide a total score
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start22 Jan 2019
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Knaapen, Amsterdam UMC, location VUmc
- Investigators
- Paul Knaapen, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805048
- Sponsor's protocol ID
- Amsterdam UMC
- Acronym
- PROCTOR
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Winter RW, Hoek R, Walsh SJ, Hanratty CG, Sprengers RW, Twisk JWR, Vegting I, Schumacher SP, Bom MJ, Verouden NJ, Henriques JP, Wilgenhof A, Viscusi MM, Teeuwen K, Opolski MP, Wolny R, Agostoni P, van Kuijk JP, Scholzel BE, Kraaijeveld AO, van Geuns RM, Dirksen MT, Heestermans AACM, Dens J, Bennett J, Haine SEF, Delewi R, Nap A, Spratt JC, Knaapen P; PROCTOR Trial Investigators. PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):269-282. doi: 10.1016/j.jacc.2025.09.1577. Epub 2025 Oct 28.
PubMed 41159978
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRcutaneous cOronary Intervention of Native Coronary arTery Versus Venous Bypass Graft in Patients With Prior cORonary Artery Bypass Graft Surgery - the PROCTOR Trial
- ClinicalTrials.gov ID
- NCT03805048
- Acronym / sponsor ID
- PROCTOR / Amsterdam UMC
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Dysfunctional venous bypass graft, Second generation DES, CABG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. 584 patients with a a clinical indication for percutaneous coronary intervention and a dysfunctional graft on the target vesselional venous bypass graft are planned to be enrolled during 3 years.Study objectives: to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization. 1 year and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.The CT-substudy and the PROCTOR registry is planned to be conducted too.
Detailed description
Multi-centre, randomised clinical trial with anticipated 17 European centres: in the Netherlands, Belgium, Germany and UK. Patients with a dysfunctional bypass graft with a clinical indication for revascularization will be randomized to either PCI of the native vessel or PCI of the dysfunctional venous bypass graft. The CT-substudy and the PROCTOR registry is planned to be conducted too (details included in the flow chart).
CCTA substudy Selected patients will be approached for participation in the CCTA substudy of the trial. Participation in this substudy is optional. After written informed consent is obtained patients will undergo a CCTA in an out-patient setting. The CCTA will be performed before the PCI procedure.
PROCTOR registry
Patients can be approached for the registry when :
- PCI have been deemed clinically indicated by the local hartteam, and
- both the lesions in the native vessel and the dysfunctional graft have been deemed technically feasible by the local hartteam,
- the patient does not meet the in- and exclusion criteria for the randomized PROCTOR study or declines to participate in the randomized study.
Patients will be approached for participation and will have one week to consider. Written informed consent is mandatory for participating in the registry. Patients will be followed by telephonic follow-up after 1, 3, and 5 years. No additional study procedures will be performed.
Study objectives:to investigate the clinical and angiographic outcome of native vessel PCI compared to PCI of venous bypass graft in patients with a dysfunctional venous bypass graft with a clinical indication for revascularization.
- PROCTOR main study
- Investigate the clinical outcome of native vessel PCI vs. PCI of dysfunctional venous bypass graft with a clinical indication for revascularisation
- CCTA substudy
- Investigate prognostic value of CT-derived plaque characteristics for occurrence of MACE following bypass graft PCI
- Investigate value of CCTA in guidance of CTO PCI procedures
- PROCTOR Registry - Investigate long-term clinical outcomes in patients with dysfunctional venous bypass graft and an indication for PCI whom are not included in randomised main study.
All patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Patients will be eligible for inclusion if revascularization is deemed clinically indicated and technically feasible for PCI by the local heart team. The indication for revascularization will be based on symptoms and evidence of ischemia and viability in the target vessel territory. The lesion in the native vessel must be bypassed by a single venous graft or must be connected to a jump graft at the most distal anastomosis of that graft. In jump grafts, the lesion must be located distally to the second-to-last anastomosis. In case both the lesion in the native vessel and the lesion in the graft are deemed technically feasible for PCI, patients will be eligible for inclusion in the randomized study after consideration of in- and exclusion criteria. Patients who do not meet these criteria or decline to participate in the randomized study will be approached for inclusion in the registry. Subsequently patients will be approached for study participation. After being informed, patients will have at least 24 hours to consider participation. An independent physician will be available for extra information, if desired. After obtaining written informed consent, patients will be randomized to either native vessel PCI or PCI of the venous bypass graft. In case of PCI failure, a second attempt can be performed by the operator within one month.
If feasible, it is possible to perform a second attempt in another high-volume center. When successful PCI cannot be accomplished in one or two attempts, cross-over to the other treatment arm may be used as bailout strategy to restore myocardial blood flow to the distal vascular bed of the vessel. Randomization will be performed using an interactive Web-based randomization system, Open Clinica. After 1 and 5 years, follow-up will be performed by means of a telephonic visit. After 3 years patients will be admitted to undergo a control invasive angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to either native vessel PCI or PCI of the venous bypass graft in a 1:1 fashion. Randomization will be performed using an interactive Web-based randomization system, Open Clinica
| Arm | Type | Receives |
|---|---|---|
| Native Vessel PCI | Other | Procedure: Percutaneous coronary interventionAll patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the native vessel will be performed according to current standard. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using four complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation and retrograde dissection reentry. |
| Graft PCI | Other | Procedure: Percutaneous coronary interventionAll patients with a significant stenosis (>50% on coronary angiography) in a venous bypass graft discussed in the local heart team for revascularization will be screened for potential inclusion in the study. Percutaneous coronary intervention of the bypass graft will be performed following current standards and at the discretion of the operating interventional cardiologist. Only commercially available second generation DES will be used in the treatment of bypass grafts. The second generation DES used in this study will be the XIENCE Sierra stent. The use of a filter-wire during the procedure will be left at the discretion of the operator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A significant stenosis (>50% on angiography) in a venous bypass graft
- Clinical indication for revascularization as determined by the local heart team (based on symptoms, documented ischemia, and viability).
- Both the native lesion and the venous graft lesion must be deemed suitable for PCI with a commercially available second generation DES.
- Informed consent must be obtained
Key exclusion criteria (13 listed)
- < 18 years of age
- Target vessel diameter < 2.5 mm
- CABG performed less than 1 year prior to inclusion
- Diameter of the graft > 5.5 mm
- Aneurysm formation in the bypass graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionPCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS. | Procedure or surgery | Graft PCI, Native Vessel PCI |
Primary outcome
Amount and type of Major Adverse Cardiac Events
Time frame: 3 year follow up
The total number and specification of major adverse cardiac events (all-cause mortality, non-fatal myocardial infarction, or clinically driven target lesion revascularization).
13 secondary outcomes
Amount and type of Major Adverse Cardiac Events
Time frame: 1 and 5 year follow-up
Amount of patients that have passed away
Time frame: 1, 3 and 5 year follow-up
Number of non-fatal myocardial infarctions
Time frame: 1, 3 and 5 year follow-up
Number of clinically driven target lesion revascularizations
Time frame: 1, 3 and 5 year follow-up
Number of target vessel revascularizations
Time frame: 1, 3 and 5 year follow-up
Number of target vessel failure.
Time frame: 1, 3 and 5 year follow-up
Number of non-fatal myocardial infarctions.
Time frame: >48 hours after PCI
Number of PCI-related myocardial infarctions.
Time frame: 1, 3 and 5 year follow-up
Specific angiographic outcome
Time frame: 3-year follow up
Quality of life assessed by SAQ
Time frame: 1, 3 and 5 year follow-up
Quality of life assessed by CCS
Time frame: 1, 3 and 5 year follow-up
Quality of life assessed by RDS
Time frame: 1, 3 and 5 year follow-up
Composite score of quality of life
Time frame: 3-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 41159978de Winter RW, Hoek R, Walsh SJ, Hanratty CG, Sprengers RW, Twisk JWR, Vegting I, Schumacher SP, Bom MJ, Verouden NJ, Henriques JP, Wilgenhof A, Viscusi MM, Teeuwen K, Opolski MP, Wolny R, Agostoni P, van Kuijk JP, Scholzel BE, Kraaijeveld AO, van Geuns RM, Dirksen MT, Heestermans AACM, Dens J, Bennett J, Haine SEF, Delewi R, Nap A, Spratt JC, Knaapen P; PROCTOR Trial Investigators. PCI of Native Coronary Artery vs Saphenous Vein Graft After Prior Bypass Surgery: A Multicenter, Randomized Trial. J Am Coll Cardiol. 2026 Jan 27;87(3):269-282. doi: 10.1016/j.jacc.2025.09.1577. Epub 2025 Oct 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Knaapen principal investigator
Amsterdam UMC
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Amsterdam UMC, location VUmc at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Netherlands, United Kingdom, Belgium, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount and type of Major Adverse Cardiac Events (time frame: 3 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.